Phase I BKM120/Abraxane in Solid Tumors, Expansion Phase Recurrent Endometrial or Ovarian Cancer

Learn more about:
Related Clinical Trial
Efficacy of Paxman Scalp Cooling to Prevent Chemo Induced Alopecia in Black Patients With Breast or GYN Cancers Anti-ALPP CAR-T Cells Immunotherapy for Ovarian and Endometrial Cancer Pilot Trial of SP-2577 Plus Pembrolizumab in Select Gynecologic Cancers Relationship of Endometrial Cancer and Serum Soluble L1CAM Level Study of CYH33, an Oral α-specific PI3K Inhibitor in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer A Prospective Study Comparing Three Injection Sites to Detect Sentinel Lymph Nodes in Endometrial Cancer Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer Use of an Intrauterine Manipulator and Its Correlation With Positive Peritoneal Cytology in Early Stage Endometrial Cancers Intraoperative Examination of Sentinel Node in Endometrial Cancer (TRSGO-SLN-003) Tumor Grade Determines PD-1/PDL-1 Expression The UPPROACH (Upfront Intensity Modulated Proton Beam Therapy) Approach Bone Marrow Sparing Image-Guided Radiation Therapy (RT) Incorporating Novel Use of GCSF and FDG-PET Imaging To Assess and Compare the Performance Two Approach for Sentinel Lymph Node (SNLD) Biopsy for Endometrial Cancer Mindfulness in Endometrial and Cervical Cancer Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer European Collaborative Multicenter Observational Study: Modular Treatment With PMMR and Targeted Compartmental Pelvic Lymphadenectomy Followed by Therapeutic Pelvic and Paraaortic Lymphadenectomy in Node Positive Disease for Locoregional Control in Endometrial Cancer FIGO Stages I-III PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Colorectal, or Gastric Cancer Sentinel Node in Endometrial Cancer Arsenic Trioxide in Recurrent and Metastatic Ovarian Cancer and Endometrial Cancer With P53 Mutation A Study of Targeted Agents With Atezolizumab for Patients With Recurrent or Persistent Endometrial Cancer Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy. Adjuvant Hypofractionated Whole Pelvis Radiation Therapy in Endometrial Cancer Reliability and Interest of Circulating Tumor DNA in Endometrial Cancers. Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer Tisotumab Vedotin Continued Treatment in Patients With Solid Tumors. CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules Effectiveness of Care in Certified Cancer Centres in Germany PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors Survivorship Promotion In Reducing IGF-1 Trial Feasibility of a Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel Study of PF‑06940434 in Patients With Advanced or Metastatic Solid Tumors. Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients Gyn Onc Prehab Study Adapting Multiple Behavior Interventions That Effectively Improve Cancer Survivor Health Cancer Survivor Health Pembrolizumab Combined With Itacitinib (INCB039110) and/or Pembrolizumab Combined With INCB050465 in Advanced Solid Tumors Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers BP1001-A in Patients With Advanced or Recurrent Solid Tumors Dose Finding Study Of PF-05212384 With Paclitaxel And Carboplatin In Patients With Advanced Solid Tumor Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects With Advanced Solid Malignancies Clinical Database and Biobank of Patients With Gynecologic Neoplasms Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors Continuation of Follow-up of DES-Exposed Cohorts A Study of Patients Receiving High-Dose Rate Brachytherapy Effects of Centering Pre-operative Counseling on Patient Reported Anxiety Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer Exploring HIFU as a Treatment for Rectal and Other Pelvic Cancers Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies – (FIGHT-101) COM701 in Subjects With Advanced Solid Tumors A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors FPA150 in Patients With Advanced Solid Tumors Study to Evaluate PM01183 in Combination With Olaparib in Advanced Solid Tumors Cytokine Regulation of Natural Killer Receptors in Inhibiting Activated T Cell Function Carboplatin-cyclophosphamide Combined With Atezolizumab Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Procedures. Study of Vaginal Dilator Use After Pelvic Radiotherapy Hula, a Physical Activity Intervention for Female-Cancer Survivors Clinical Characters of the Diagnosis and Treatment of Gynecological Malignant Tumors in China : A Real World Study Predictive Clinical and Biological Parameters in Gynecological Cancer – GC-BIO-IPC 2013-010 An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis Comparison of the Effects of Fentanyl, Oxycodone, Butorphanol on Gastrointestinal Function Safety of BKM120 Monotherapy in Advanced Solid Tumor Patients Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study Phase I BKM120/Abraxane in Solid Tumors, Expansion Phase Recurrent Endometrial or Ovarian Cancer A Study of Combination of Temsirolimus (Torisel®) and Pegylated Liposomal Doxorubicin (PLD, Doxil®/Caelyx®) in Advanced or Recurrent Breast, Endometrial and Ovarian Cancer Extended Follow-up of Columbia, MO Serum Bank Participants A Study of LY353381 (Arzoxifene) for Patients Who Benefitted From This Drug in Other Oncology Trials and Wished to Continue Treatment A Study of Sacituzumab Govitecan in Metastatic Solid Tumors (TROPICS-03) Can the iKnife Distinguish Between Normal and Malignant Endometrial Tissue? Diagnostic Accuracy of MRI, DWI MRI, FDG-PET/CT and FEC PET/CT in the Detection of Lymph Node Metastases in Surgically Staged Endometrial and Cervical Carcinoma Phase 1/2a Evaluation of AL3818 in Subjects With Recurrent or Metastatic Endometrial, Ovarian or Cervical Cancer (AL3818-US-001) Follow-up of Gynecological Cancer Patients, Their Needs and Expectations, A Cooperation Project Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies Open-label Phase 1b Study of ARQ 092 in Combination With Anastrozole ROGYcare: The Impact of a Cancer Survivorship Care Plan on Patient Reported Outcomes and Health Care Providers Macrobiotic Diet and Flax Seed: Effects on Estrogens, Phytoestrogens, & Fibrinolytic Factors Safety and Tolerability of DS-7423 in Subjects With Advanced Solid Malignant Tumors Intensity Modulated Radiotherapy (IMRT) for the Pelvis Post-Hysterectomy The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study. Multiorgan Metabolic Imaging Response Assessment of Abemaciclib Determining the Sensitivity of Sentinel Lymph Nodes Identified With Robotic Fluorescence Imaging Clinical Trial of PM00104 (Zalypsis®) in Patients With Advanced and/or Metastatic Endometrial or Cervical Cancer Previously Treated With One Line of Systemic Chemotherapy Biomarkers for Gynecologic Cancer A Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping Application of Tachosil During Lymphadenectomy Evaluation of Indocyanine Green-guided Systematic Pelvic Lymphadenectomy in Endometrial and Cervical Cancer Study of Pembrolizumab, Radiation and Immune Modulatory Cocktail in Cervical/Uterine Cancer A Controlled Study of Quality of Life and it’s Related Factors Among Gynecological Cancer Survivors A Novel Tapered Applicator for Vaginal Vault Brachytherapy Motivational Interviewing to Increase Physical Activity Behaviour in Cancer Patients Quality of Life in Survivors of Gynecologic Cancer PET-CT vs. Integrated MR-PET Scanning of GYN Cancers Endometrial Polyps: Pathophysiology and Clinical Consequences Radiation Therapy in Uterine Cancer: Dosimetry Analysis, Clinical Implication, and Survival Analysis A Phase 2 Feasibility Study of Abraxane and Carboplatin in Epithelial Neoplasms of the Uterus 2D vs 3D Planning for High-Dose Rate (HDR) Gynecological Brachytherapy Targeted Disruption to Cancer Metabolism and Growth Through Dietary Macronutrient Modification Evaluation of the Proliferative Activities of Insulin Analogues in Primary Human Tumor Cells Trial of Maintenance With Niraparib- Uterine Serous Carcinoma CerviPrep for Applying Topical Gemcitabine to the Cervix in Treating Patients With Primary Endometrial, Cervical, or Ovarian Epithelial Cancer Antitumoral Activity and Safety of AEZS-108 in Women With LHRH Receptor Positive Gynecological Tumors Bone Mineral Density and Subsequent Cancer Risk Bevacizumab and Rucaparib in Recurrent Carcinoma of the Cervix or Endometrium Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients Non-Hormonal Vaginal Moisturizer in Hormone-Receptor Positive Postmenopausal Cancer Survivors Experiencing Estrogen Deprivation Symptoms on Vulvovaginal Health OSCAR ENDO One Stop Assessment of Risk for Endometrial Hyperplasia and Cancer Endometrial Changes in Breast Cancer Women With or Without Hormonal Therapies Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen Cancer of the Uterus and Treatment of Stress Urinary Incontinence Carboplatin/Taxol/Ridaforolimus in Endometrial, Ovarian and Solids Multi-omics Study on the Pathogenesis of Malignant Transformation of Adenomyosis Pharmacology Study of Aerosolized Liposomal 9-Nitro-20 (S)-Camptothecin (L9NC) Assessment of Screening Modalities for Gynecologic Cancers Compliance to Vaginal Dilation Therapy in Patients Who Have Undergone Radiation Therapy For Stage IB, Stage IIA, Stage IIB, Stage IIIA, or Stage IIIB Cervical Cancer or Stage IA, Stage IB, Stage IIA, or Stage IIB Endometrial Cancer Phase II Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC) Biomarker Guided Treatment in Gynaecological Cancer Positron Emission Tomography (PET) Imaging Studies With NIS Reporter Tachosil for the Prevention of Symptomatic Lymph Cysts A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer Exploring the Potential of Novel Biomarkers Based on Plasma microRNAs for a Better Management of Pelvic Gynecologic Tumors Fertility-sparing Management Using High-dose Oral Progestin in Young Women With Endometrial Cancer Multimedia Aid Gynecologic Counseling and Consent Phase I/IIa Trial of Folate Binding Protein Vaccine in Ovarian Cancer Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC Pembrolizumab With Ataluren in Patients With Metastatic pMMR and dMMR Colorectal Carcinoma or Metastatic dMMR Endometrial Carcinoma: the ATAPEMBRO Study Translating Healthy Lifestyle Interventions for Cancer Survivors Pilot Study: Can Ultrasound Guided Biopsy be Used as an Alternative to Hysteroscopy? Screening for Endometrial Abnormalities in Overweight and Obese Women A Trial for Patients With Advanced/Recurrent Endometrial Cancer Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer Intra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma Pembro/Carbo/Taxol in Endometrial Cancer Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers. Robot-assisted Laparoscopic Hysterectomy-RALH- Postoperative Complications, Quality of Life and Health Economics Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium Lymphoseek as Lymphoid Tissue Targeting Agent in Patients With Cancer of the Endometrium Vaginal Cuff Brachytherapy Fractionation Study MK-3475 Immunotherapy in Endometrial Carcinoma Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer Anxiety and Distress Levels in Women With Suspected Endometrial Cancer Advanced Methods for Cancer Detection by Vaginal Screening END-1: First Line Chemotherapy for Advanced or Recurrent Endometrial Carcinoma With Carboplatin and Liposomal Doxorubicin Trial of Letrozole + Palbociclib/Placebo in Metastatic Endometrial Cancer Application of Thrombin Gel Matrix for the Prevention of Lymphocele in Patients With Endometrial Cancer. Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer Clinical Trial of Ridaforolimus Compared to Progestin or Chemotherapy for Advanced Endometrial Carcinoma (MK-8669-007 AM6) Metformin With the Levonorgestrel-Releasing Intrauterine Device for the Treatment of Complex Atypical Hyperplasia (CAH) and Endometrial Cancer (EC) in Non-surgical Patients Prospective Randomised Phase II Trial Evaluating Adjuvant Pelvic Radiotherapy Using Either IMRT or 3-Dimensional Planning for Endometrial Cancer. ICORG 09-06 Quality of Life After Robotic Surgery for Endometrial Cancer SYD985 in Patients With HER2-expressing Recurrent, Advanced or Metastatic Endometrial Carcinoma Pembrolizumab With Axitinib in Recurrent Endometrial Cancer A Study of Various Treatments in Serous or p53 Abnormal Endometrial Cancer Genistein in Preventing Breast or Endometrial Cancer in Healthy Postmenopausal Women Prognostic Impact of Programmed Death Ligand-1 Expression in Advanced Endometrial Cancer Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer Evaluation of Thiol Disulfide Balance in Stage 1 Endometrium Cancer Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer Maintenance With Selinexor/Placebo After Combination Chemotherapy in Endometrial Cancer [SIENDO] BEZ235 Trial in Patients With Advanced Endometrial Carcinoma Laparoscopic Approach to Cancer of the Endometrium Systematic Pelvic Lymphadenectomy Versus no Lymphadenectomy in Clinical Stage I-II Endometrial Cancer A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer Screening of Biomarkers on Endometrial Cancers Papillary Serous Carcinoma of the Endometrium Sentinel Node Biopsy in Endometrial Cancer ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma Selective Inhibitor of Nuclear Export, Selinexor (KPT-330) in Combination With Paclitaxel and Carboplatin in Patients With Advanced Ovarian or Endometrial Cancers A Study to Assess the Efficacy and Safety of ABTL0812 Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma/Intraepithelial Neoplasia Accuracy of Sentinel Lymph Node Biopsy in Nodal Staging of High Risk Endometrial Cancer Value of Diffusion Weighted Magnetic Resonance Imaging in Detection of Recurrent Disease in Surgically Treated Cervical and Endometrial Cancer Patients Docetaxel in Treating Patients With Recurrent or Persistent Endometrial Carcinoma (Cancer) DOvEEgene: Diagnosing Ovarian and Endometrial Cancer Early Using Genomics Exercise and Healthy Diet or Standard Care in Patients in Remission From Stage I or Stage II Endometrial Cancer A Phase II, Single-Arm Study of RAD001 (Everolimus), Letrozole, and Metformin in Patients With Advanced or Recurrent Endometrial Carcinoma Effect of a Lifestyle Intervention on Nutritional Status and Prognosis of Endometrial Cancer Survivors Study of Vintafolide (MK-8109, EC145) in Participants With Advanced Ovarian and Endometrial Cancers (MK-8109-007, EC-FV-02) Study of BN83495 in Post-menopausal Women With Endometrial Cancer Post-chemotherapy Exercise as an Intervention in Endometrial Cancer Survivors Efficacy Study of Chemotherapy Followed by Radiation Therapy to Treat Endometrial Cancer Stratifying Endometrial Cancer Patients Using a PET/MRI Prognostic Model Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer Prevalence of Self Reported Lymphedema in Patients With Endometrial Cancer Feasibility Study: Accuracy of Biomarker in Detection of Endometrial Cancer Rucaparib and Nivolumab in Patients With Prostate or Endometrial Cancer Upper Vaginectomy Versus Brachytherapy in Patients With Early Stage Endometrial Cancer Treated With Laparoscopic Surgery Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer Protein-Sparing Modified Fast Intervention for Weight Loss in Obese Endometrial Cancer Survivors Expression of Altered Glycosyltransferases, Mucins, and RTKs in Human Ovarian and Endometrial Cancers Sentinel Lymph Node Dissection (SLND) in Patients With Apparent Early Stage Endometrial Cancer Effect of Fertility-sparing Therapy of Early Endometrial Cancer Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer Indocyanine Green and Near-infrared Fluorescence Imaging to Detect Sentinel Lymph Nodes in Patients With Endometrial Cancer A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer Pemetrexed Disodium in Treating Patients With Persistent or Recurrent Endometrial Cancer Pembrolizumab in Ultramutated and Hypermutated Endometrial Cancer Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive Combination Chemotherapy With Nintedanib / Placebo in Endometrial Cancer Programmed Death-1(PD-1) Inhibitor Combined With Progesterone Treatment in Endometrial Cancer Different Risk Stratification Models for Prediction of Lymph Node Involvement in Endometrial Carcinoma ONC201 in Recurrent or Metastatic Type II Endometrial Cancer Endometrial Cancer Frontline Immunotherapy Combined With Radiation and Chemotherapy in High Risk Endometrial Cancer TSR-042 in Addition to Standard of Care Definitive Radiation for Inoperable Endometrial Cancer Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease Bristol-Myers Squibb Dasatinib Src Inhibition in Endometrial Cancer Lymphedema in Endometrial Cancer Evaluation of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma Combination Chemotherapy With or Without G-CSF in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia High Intensity Interval Training in Endometrial Cancer A Pilot Study to Determine the Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion Doxorubicin Hydrochloride Liposome and Carboplatin in Treating Patients With Recurrent, Stage III, or Stage IV Primary Endometrial Cancer Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer Single Agent ONC201 in Recurrent or Metastatic Endometrial Cancer 3 Year Recurrence Free Survival in Ultra-low-risk Endometrial Cancer A Study of Ketogenic Diet in Newly Diagnosed Overweight or Obese Endometrial Cancer Patients Sentinel Node Detection in Endometrial Cancer: A Consolidation Study on Detection Rates of Metastatic Disease Biomarkers for Diagnosis and Prognosis of Endometrial Carcinoma Chemotherapy or Observation in Stage I-II Intermediate or High Risk Endometrial Cancer Retrospective Case Study Examining Patient Outcomes Compared to the ChemoFx Assay in Endometrial Cancer Patients Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer Disseminated Endometrial Cancer Cells During Sonohysterography Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer PORTEC-4a: Molecular Profile-based Versus Standard Adjuvant Radiotherapy in Endometrial Cancer ENdometrial Cancer SURvivors’ Follow-up carE (ENSURE): Less is More? Pre-operative Studies for Prediction of Lymph Nodes Involvement in Endometrial Cancer Patients Crizotinib in c-MET Mutation Metastatic/Recurrent/Persistent Endometrial Cancer Thunderbeat Technology vs Standard Bipolar Electro-surgery in Total Laparoscopic Hysterectomy With Pelvic Lymphadenectomy for Endometrial Cancer Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer Evaluation of the Molecular Effects of Metformin on the Endometrium in Patients With Endometrial Cancer Study of Niraparib and TSR-042 in Recurrent Endometrial Cancer Endometrial Cancer – LOHP Alone and With 5FU Exemestane in Advanced and Recurrent Endometrial Carcinoma SLNM in Endometrial Cancer Combined With OSNA FESPET Study: Female EStrogen recePtor in Endometrial Cancer Treatment Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer A Pre-Op Window Study Evaluating Anti-Proliferative Effects of Atorvastatin on the Endometrium the Effectiveness of a Weight Management Program in Patients Who Have Completed Treatment for Endometrial Cancer Preoperative Window Study of Metformin for the Treatment of Endometrial Cancer Intravenous Weekly Topotecan In Subjects With Recurrent Or Persistent Endometrial Cancer Endometrial Cancer Biomarker Changes Following Exposure to Metformin Letrozole and RAD001 With Advanced or Recurrent Endometrial Cancer Neoadjuvant Celecoxib in Newly Diagnosed Patients With Endometrial Carcinoma Safety and Efficacy of Metronomic Cyclophosphamide, Metformin and Olaparib in Endometrial Cancer Patients Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer Role of Uterine Manipulator in Hysterectomy – Ro.Man.HY TREC Lifestyle Beyond Cancer Study in Endometrial Cancer Survivors Mirena® ± Metformin as Fertility-preserving Treatment for Young Asian Women With Early Endometrial Cancer Lifestyle Change and Quality of Life in Obese Patients With Stage I/II Endometrial Cancer in Remission Compare the Performance of Targeted Biopsy Versus Aspiration Biopsy With a Pipette for the Diagnosis of Endometrial Cancer External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I Endometrial Cancer Cost-utility of Ambulatory Surgery in the Management of Endometrial Cancer(AMBU-ENDO) Phase II Study of Atezolizumab + Bevacizumab in Endometrial Cancer Aminopterin in Treating Patients With Recurrent or Refractory Endometrial Cancer Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy Letrozole in Treating Women With Recurrent or Metastatic Endometrial Cancer Epidemiological Analysis on Endometrial Cancer in Guangdong Province of China Window of Opportunity Study of Pembrolizumab in Early Stage, High Grade Obesity-driven Endometrial Cancer Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer Doxorubicin, Paclitaxel, and Carboplatin in Treating Patients With Primary Stage III, Stage IV, or Recurrent Endometrial Cancer Prospective, Observational Study of Low-risk Criteria for Node Metastasis in Endometrial Cancer A Safety and Efficacy of CCRT With Paclitaxel as Adjuvant Therapy to Post-Operative Advanced Endometrial Cancer Patients VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients. Abemaciclib With Letrozole in Recurrent or Persistent Endometrial Cancer Feasibility Study of Laparoendoscopic Single Site Surgical Staging for Endometrial Cancer Photoacoustic Endoscopy in Endometrial Cancer RAD001 in Recurrent Endometrial Cancer Patients Carboplatin, Paclitaxel With or Without Avelumab in Advanced or Recurrent Endometrial Cancer Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer Psychosocial Benefits of Exercise in Endometrial Cancer Survivors Evaluating the Effect of Perioperative Caloric Restriction Program on Perioperative Outcomes in Patients With Obesity and Endometrial Cancer Letrozole in the Treatment of Advanced or Recurrent Hormone Receptor Positive Endometrial Cancer A Study of Dostarlimab (TSR-042) Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Patients With Recurrent or Primary Advanced Endometrial Cancer Selective Targeting of Adjuvant Therapy for Endometrial Cancer (STATEC) Scale Down for Endometrial Cancer Feasibility Study Using the Xoft System for the Treatment of Endometrial Cancer Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer Trial Between Two Follow up Regimens With Different Test Intensity in Endometrial Cancer Treated Patients GINECO-EN102b – BKM120 as Monotherapy in the Treatment of Initial or Recurrent Metastatic Endometrial Cancer Preliminary Study of Endometrial Hyperplasia Groundwork for a Study to Define Precursors of Endometrial Cancer Biomarkers in Tissue Samples From Patients With Stage I or Stage III Endometrial Cancer Intraoperative Pathological Evaluation for Surgical Treatment & Staging for Endometrial Cancer Patient’s Experience and Choice Between Investigations for Endometrial Cancer in Postmenopausal Bleeding Factors Affecting the Prognosis of Patients With Endometrial Cancer Anti-PD-1 Antibody Combined With Anlotinib in the Treatment of Endometrial Cancer 2D Versus 3D Radical Laparoscopic Hysterectomy for Endometrial Cancer: a Prospective Randomized Trial Risk Factors for Endometrial Cancer in Black Women Retrospective Study to Evaluate the Feasibility of Ovarian Preservation in Patients With Endometrial Carcinoma Sexual Functioning in Endometrial Cancer An Endometrial Cancer Study for Women With Recurrent or Persistent Endometrial Cancer A Randomized, Controlled, Comparative Study of a Levonorgestrel Intrauterine System for the Prevention of Endometrial Cancer in Patients Aged 40-50 With BMI Greater Than 35 Molecular Staging of Endometrial Cancer Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Recurrent, Advanced, or Metastatic Endometrial Cancer Sentinel Node Mapping in High Risk Endometrial Cancer Cytologic Analysis of Distention Media as a Screening Test for Endometrial Cancer Selective Surgical Staging for the Treatment of Endometrial Cancer Based on Intraoperative Consultation Can 3D Ultrasound be Used as an Alternative to MRI to Assess Myometrial Invasion in Endometrial Cancer? Hysteroscopic Lymphatic Mapping for Endometrial Cancer Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women With Suspected Ovarian or Endometrial Cancer Raloxifene in Treating Patients With Persistent or Recurrent Endometrial Cancer The Effects of the Endocrine System on Endometrial Cancer CT Assessment of BMI in Endometrial Cancer Patients MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback Study of the Weekly Oral RAD001 in Combination With Oral Topotecan in Patients With Advanced or Recurrent Endometrial Cancers The Role of Functional MRI and Doppler Sonography in Assessing Blood Vessel Formation Within the Tumors of Endometrial Cancer Patients A Phase 2 Study of Oral MKC-1 in Patients With Ovarian or Endometrial Cancer Adjuvant Stereotactic Pelvic Irradiation in Endometrial Cancer Estrogen, Diet, Genetics and Endometrial Cancer A Phase 2 Study of Mirvetuximab Soravtansine (IMGN853) and Pembrolizumab in Endometrial Cancer (EC) Pilot Study Using a PET Gamma Probe to Evaluate Lymph Nodes in Endometrial Cancer AP23573 in Female Adult Patients With Recurrent or Persistent Endometrial Cancer (8669-019)(COMPLETED) Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG Lymph Node Mapping in Patients With Endometrial Cancer Effect of Uterine Manipulator on Recurrence and Mortality of Endometrial Cancer Adjuvant Sequential & Concurrent CarboTaxol + Radiotherapy for High Risk Endometrial Cancer Study of Genes and the Environment in Patients With Endometrial Cancer in the East Anglia, Oxford, Trent, or West Midlands Regions of the United Kingdom Racial Disparity in Endometrial Cancer Follow-up of Endometrial Cancer Patients Can Staging Magnetic Resonance Imaging (MRI) Features Prognosticate Patients Presenting With Endometrial Cancer? Endometrial Cancer Diet and Exercise Treatment With Medroxyprogesterone Acetate Plus LNG-IUS in Young Women With Early Stage Endometrial Cancer BKM120 in Advanced, Metastatic, or Recurrent Endometrial Cancers Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients The DETECT Study: Discovery and Evaluation of Testing for Endometrial Cancer in Tampons Human Epididymis Protein 4 in Endometrial Carcinoma The Multicentic Trial in Fertility-sparing Treatment and Ovarian Preservation Management for Early Endometrial Cancer Efficacy of PET/MRI in Detecting Metastatic Disease in Endometrial Cancer Study of Post Operative Pain in Endometrial Cancer Robotic Versus Laparotomy Study of Insulin Resistance and Endometrial Cancer in Harris County, Texas Physical Activity After Endometrial Cancer Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery. The Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer Investigating the Use of Fluorescence Imaging in Endometrial Cancer Surgery Carboplatin, Docetaxel, and Radiation Therapy in Treating Patients With Stage III/IV, or Recurrent Endometrial Cancer Dendritic Cells for Immunotherapy of Metastatic Endometrial Cancer Patients Urinary miRNA in Endometrial Cancer Study Ketohexokinase Isoforms in Endometrial Cancer. PET/CT in the Management of Patients With Early Stage Endometrial Cancer Linking Obesity and Estrogen-responsive Genes in Endometrial Cancer Telephone Follow-up After Treatment for Endometrial Cancer Study of Lenvatinib in Subjects With Advanced Endometrial Cancer and Disease Progression HE4 is a Beneficial Biomarker in Endometrial Cancer Transvaginal Natural Orifice Endoscopic Surgery for Extremely Obese Patients With Early-stage Endometrial Cancer Endometrial Cancer Testing With Vaginal and Endometrial Cell Samples

Brief Title

Phase I BKM120/Abraxane in Solid Tumors, Expansion Phase Recurrent Endometrial or Ovarian Cancer

Official Title

A Phase I Trial of BKM120 in Combination With Weekly Nabpaclitaxel (Abraxane®) in Patients With Advanced Solid Tumors Followed by a Dose Expansion Phase in Patients With Recurrent Endometrial or Recurrent Ovarian Cancer

Brief Summary

      The purpose of the first part of this study or the dose escalation portion of the study is to
      determine what dose of BKM120 and Abraxane is safe to give when the two drugs are used at the
      same time in patients who are diagnosed with a solid cancer. A solid cancer is a cancer that
      does not involve the blood, bone marrow or lymph nodes. Dose escalation determines the least
      toxic and most effect dose of this drug combination for treatment. Once this dose is
      established, it will be used for the dose expansion phase of the study where we will
      determine the effect of BKM120 and Abraxane in women diagnosed with a recurrent endometrial
      or ovarian cancer. We will see whether the combination of both drugs improves the response
      and survival of patients treated on the two drug regimen. Also we will try to find out
      whether there are changes in tumors that can help us determine what patients are more likely
      to respond to BKM120 and Abraxane.
    

Detailed Description

      Primary Objectives:

        -  To determine the safety and tolerability of BKM120 in combination with weekly
           nabpaclitaxel (Abraxane®) in patients with a recurrent solid tumor and in particular a
           recurrent endometrial or ovarian cancer.

        -  To determine the MTD and DLT of BKM120 in combination with weekly nabpaclitaxel
           (Abraxane®) thereby establishing the recommended phase II dose.

      Secondary Objectives:

        -  Obtain pilot data on the clinical tumor response utilizing RECIST criteria of BKM120 in
           combination with weekly nabpaclitaxel (Abraxane®) in patients with a history of
           recurrent endometrial or a recurrent ovarian cancer.

        -  To determine the progression free survival (PFS) of patients treated with BKM120 and
           nabpaclitaxel (Abraxane®) and a history of recurrent endometrial or ovarian cancer.

        -  To explore molecular markers that my serve as potential molecular predictors of response
           including PIK3CA, mTOR, KRAS, PTEN and p53 mutations as well as amplification of ErbB2.

        -  To test the predictive value of PIK3CA and KRAS mutations in predicting response to this
           regimen in women diagnosed with a recurrent endometrial or ovarian cancer.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Secondary Outcome

 Response rate (at the end of the 3 months of therapy)

Condition

Ovarian Cancer

Intervention

BKM120

Study Arms / Comparison Groups

 Treatment (BKM120 in Combination with Weekly Nabpaclitaxel)
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

February 2015


Primary Completion Date

February 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥ 18 years with a recurrent solid tumor in the Phase I portion of the trial or in
             the Phase II portion of the trial a recurrent endometrial or ovarian cancer, not
             amenable to treatment by surgery, radiotherapy or chemotherapy.

          -  ECOG performance status £ 2

          -  Patients must have at least one site of measurable disease defined by RECIST 1.1
             criteria. If the patient has received prior radiation therapy one measurable lesion
             must be outside the irradiated field. Lesions within an irradiated field will be
             followed as non-target lesions and considered evaluable. If the only site of
             measurable disease is within a previously irradiated field then 6 months must have
             elapsed between the completion of radiation therapy and entry on study to be
             considered measurable.

          -  Patients with a recurrent ovarian cancer must have received at least one prior
             platinum containing regimen.

          -  Patients diagnosed with a platinum sensitive ovarian cancer may be enrolled if they
             will no longer benefit from treatment with a platinum agent as determined by their
             physician or it would be detrimental to treat the patient with a platinum agent due to
             underlying medical problems.

          -  Adequate bone marrow function as shown by: ANC ≥ 1.0 x 109/L, Platelets ≥ 100 x 109/L,
             Hgb > 9 g/dL

          -  Total calcium (corrected for serum albumin) within normal limits (biphosphonate use
             for malignant hypercalcemia control is not allowed)

          -  Magnesium within normal limits for the institution.

          -  Potassium within normal limits for the institution

          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within normal
             range (or ≤ 3.0 x upper limit of normal (ULN) if liver metastases are present)

          -  Serum bilirubin within normal range. For patients with liver metastases, serum
             bilirubin ≤ 1.5 x ULN. For patients with well documented Gilbert Syndrome total
             bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range. )

          -  Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL/min

          -  Negative serum pregnancy test within 72 hours before starting study treatment in women
             with childbearing potential defined as sexually mature women who have not undergone a
             hysterectomy or who have had amenorrhea for at least 12 consecutive months or women
             who have had six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL
             and estradiol < 20 pg/mL.

          -  Patients with Grade 3 or greater peripheral neuropathy.

          -  Ability to sign informed consent

          -  INR ≤ 1.5

        Exclusion Criteria:

          -  Patients who have received prior treatment with a P13K inhibitor.

          -  Patients who have received prior treatment with Nabplaclitaxel Abraxane®.

          -  Patients with a known hypersensitivity to BKM120 or to its excipients

          -  Patients with symptomatic brain metastases are excluded. However, patients with
             asymptomatic CNS metastases may participate in this trial. The patient must have
             completed any prior local treatment for CNS metastases > 28 days prior to study entry
             including radiotherapy or surgery. Patients receiving steroids for CNS metastases may
             not participate on this study.

          -  Patients with acute or chronic liver disease, renal disease or pancreatitis

          -  Patients with the following mood disorders as judged by the Investigator,
             Sub-Investigator or a psychiatrist, or as a result of patient's mood assessment
             questionnaire:

               -  Medically documented history of or active major depressive episode, bipolar
                  disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of
                  suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm
                  to others) or patients with active severe personality disorders (defined
                  according to DSM- IV) are not eligible. Note: for patients with psychotropic
                  treatments ongoing at baseline, the dose and the schedule should not be modified
                  within the previous 6 weeks prior to start of study drug.

               -  Meets the cut-off score of ≥ 12 in the PHQ-9 or a cut-off of ≥ 15 in the GAD-7
                  mood scale, respectively, or selects a positive response of "1, 2, or 3" to
                  question number 9 regarding potential for suicidal thoughts in the PHQ-9
                  (independent of the total score of the PHQ-9)

          -  Patients with diarrhea ≥ CTCAE 4.0 grade 2

          -  Patient has active cardiac disease including any of the following:

               -  Left ventricular ejection fraction (LVEF) < 50% as determined by Multiple Grated
                  acquisition (MUGA) scan or echocardiogram (ECHO)

               -  QTc > 480 msec on screening ECG (using the QTcF formula)

               -  Angina pectoris that requires the use of anti-anginal medication

               -  Ventricular arrhythmias except for benign premature ventricular contractions

               -  Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled
                  with medication

               -  Conduction abnormality requiring a pacemaker

               -  Valvular disease with document compromise in cardiac function

               -  Symptomatic pericarditis

          -  Patient has a history of cardiac dysfunction including any of the following:

               -  Myocardial infraction within the last 6 months, documented by persistent elevated
                  cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF
                  function

               -  History of documented congestive heart failure (New York Heart Association
                  functional classification III-IV)

               -  Documented cardiomyopathy

          -  Patient has poorly controlled diabetes mellitus or steroid-induced diabetes mellitus
             defined as a HgbA1C > 8% or a fasting plasma glucose level > 126 mg/dl.

          -  Patients without a history of diabetes mellitus need to have a fasting plasma glucose
             level < 126 mg/dl.

          -  Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g.,
             active or uncontrolled infection) that could cause unacceptable safety risks or
             compromise compliance with the protocol

             • Significant symptomatic deterioration of lung function. If clinically indicated,
             pulmonary function tests including measures of predicted lung volumes, DLco, O2
             saturation at rest on room air should be considered to exclude pneumonitis or
             pulmonary infiltrates.

          -  Impairment of gastrointestinal (GI) function or GI disease that may significantly
             alter the absorption of BKM120 (e.g., ulcerative diseases, uncontrolled nausea,
             vomiting, diarrhea, malabsorption syndrome, or small bowel resection). Patients with
             unresolved diarrhea will be excluded as previously indicated

          -  Patients who have been treated with any hematopoietic colony-stimulating growth
             factors (e.g., G-CSF, GM-CSF) ≤ 2 weeks prior to starting study drug. Erythropoietin
             or darbepoetin therapy, if initiated at least 2 weeks prior to enrollment, may be
             continued

          -  Patients who are currently receiving treatment with medication with a known risk to
             prolong the QT interval or inducing Torsades de Pointes and the treatment cannot
             either be discontinued or switched to a different medication prior to starting study
             drug. Please refer to Appendix E for a list of prohibited QT prolonging drugs with
             risk of Torsades de Pointes. Please recognize that this list may not be all inclusive.

          -  Patients receiving chronic treatment with steroids or another immunosuppressive agent.

             • Note: Topical applications (e.g. rash), inhaled sprays (e.g. obstructive airways
             diseases), eye drops or local injections (e.g. intr-articular) are allowed.

          -  Patients who have taken herbal medications and certain fruits within 7 days prior to
             starting study drug. Herbal medications include, but are not limited to St. John's
             wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe,
             saw palmetto, and ginseng. Fruits include the CYP3A inhibitors Seville oranges,
             grapefruit, pummelos, or exotic citrus fruits.

          -  Patients who are currently treated with drugs known to be moderate and strong
             inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or
             switched to a different medication prior to starting study drug. Please refer to
             Appendix B for a list of prohibited inhibitors and inducers of CYP3A. Please recognize
             that this list may not be all inclusive. (Please note that co-treatment with weak
             inhibitors of CYP3A is allowed).

          -  Patients who have received chemotherapy or targeted anticancer therapy ≤ 4 weeks (6
             weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug must
             recover to a grade 1 toxicity excluding alopecia before starting the trial

          -  Patients who have received any continuous or intermittent small molecule therapeutics
             (excluding monoclonal antibodies) ≤ 5 effective half- lives prior to starting study
             drug or who have not recovered from side effects of such therapy

          -  Patients who have received wide field radiotherapy ≤ 4 weeks or limited field
             radiation for palliation ≤ 2 weeks prior to starting study drug or who have not
             recovered from side effects of such therapy

          -  Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or
             who have not recovered from side effects of such therapy.

          -  Patients who are currently taking therapeutic doses of warfarin sodium or any other
             coumadin-derivative anticoagulant.

          -  Women who are pregnant or breast feeding or adults of reproductive potential not
             employing an effective method of birth control. Double barrier contraceptives must be
             used through the trial by both sexes. Oral, implantable, or injectable contraceptives
             may be affected by cytochrome P450 interactions, and are therefore not considered
             effective for this study. Women of child-bearing potential must have a negative serum
             pregnancy test ≤ 72 hours prior to initiating treatment.

               -  Women of child-bearing potential, defined as all women physiologically capable of
                  becoming pregnant, must use highly effective contraception during treatment and
                  for16 additional weeks after stopping treatment... The highly effective
                  contraception is defined as either:

                    1. True abstinence: When this is in line with the preferred and usual lifestyle
                       of the subject. Periodic abstinence (e.g., calendar, ovulation,
                       symptothermal, post-ovulation methods) and withdrawal are not acceptable
                       methods of contraception.

                    2. Sterilization: have had surgical bilateral oophorectomy (with or without
                       hysterectomy) or tubal ligation at least six weeks ago. In case of
                       oophorectomy alone, only when the reproductive status of the woman has been
                       confirmed by follow up hormone level assessment.

                    3. Male partner sterilization (with the appropriate post-vasectomy
                       documentation of the absence of sperm in the ejaculate). For female subjects
                       on the study, the vasectomized male partner should be the sole partner for
                       that patient.

                    4. Use of a combination of any two of the following (a+b):

                         1. Placement of an intrauterine device (IUD) or intrauterine system (IUS)

                         2. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or
                            cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal
                            suppository

               -  Oral contraception, injected or implanted hormonal methods are not allowed as
                  BKM120 potentially decreases the effectiveness of hormonal contraceptives.

               -  Fertile males, defined as all males physiologically capable of conceiving
                  offspring must use condom during treatment and for an additional 16 weeks after
                  stopping treatment.

               -  Female partner of male study subject should use highly effective contraception
                  during dosing of any study agent and for 16 weeks after final dose of study
                  therapy.

          -  Known diagnosis of human immunodeficiency virus (HIV) infection

          -  History of another malignancy within 3 years, except cured basal cell carcinoma of the
             skin or excised carcinoma in situ of the cervix

          -  Patient is unable or unwilling to abide by the study protocol or cooperate fully with
             the investigator
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Darlene Gibbon, MD, , 



Administrative Informations


NCT ID

NCT02117817

Organization ID

101305


Responsible Party

Sponsor

Study Sponsor

Rutgers, The State University of New Jersey

Collaborators

 Rutgers Cancer Institute of New Jersey

Study Sponsor

Darlene Gibbon, MD, Principal Investigator, Rutgers Cancer Institute of New Jersey


Verification Date

March 2015