Multiorgan Metabolic Imaging Response Assessment of Abemaciclib

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

Multiorgan Metabolic Imaging Response Assessment of Abemaciclib

Official Title

Multiorgan Metabolic Imaging Response Assessment of Abemaciclib

Brief Summary

      Open-label, phase II, basket trial. This trial is a screening program for abemaciclib
      efficacy in multiple platinum-resistant tumour types by using metabolic imaging (PERCIST) and
      RECIST v1.1 criteria.

      Based on the rate of FDG-avidity and the absence of deactivation of the Rb gene function in
      more than 95% of cases, we propose to define 5 tumour types of interest in a preliminary
      stage:

        1. Platinum-refractory esophageal adenocarcinoma (ADC)

        2. Platinum-refractory esophageal squamous cell carcinoma (SCC)

        3. Platinum-refractory cholangiocarcinoma

        4. Platinum-refractory and progressive after immunotherapy urothelial cancer

        5. Platinum-refractory endometrial cancer
    

Detailed Description

      In various solid tumour types FDG-PET/CT has been shown to identify treatment-refractory
      diseases with a high negative predictive value (NPV) through a whole-body quantitative
      assessment of treatment-induced changes in tumour glucose uptake soon after treatment
      initiation, before any structural changes are observed. Progress in the standardisation of
      FDG-PET/CT imaging and response analysis now allow its use in multicentric trials opening the
      possibilities for trials where treatment allocation will be based on early metabolic
      response. MiMe has been built on the assumption that a medication which does not induce any
      metabolic changes in a given clinical setting is unlikely to induce a significant benefit and
      does consequently not deserve further investigation as a single agent in this setting.

      MiMe, by assessing metabolic response early during the treatment course, will hopefully
      provide useful information about the drug activity in various cancer types, and about
      mechanisms of resistance through a potential ambitious translational research program with
      serial collection of circulating-tumour DNA (ct-DNA).
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Evaluate the anti-tumour activity of abemaciclib in the five tumour types studied in this trial using FDG-PET/CT during the first cycle of therapy (early FDG- PET/CT).

Secondary Outcome

 Evaluate Progression-free survival (PFS define as the time from treatment start until disease progression or death) at 24 weeks from treatment start

Condition

Esophageal Adenocarcinoma

Intervention

Abemaciclib

Study Arms / Comparison Groups

 Abemaciclib
Description:  This study contains 2 stages; during the 1st stage, a maximum of 17 patients will be enrolled in each tumour type cohort. After 13 evaluable patients have been enrolled, an interim analysis will be performed. If 3 or more patients are seen to have experienced a treatment success, then the cohort will pass into the 2nd stage in which a maximum of 20 more patients are enrolled. If 2 or less patients are seen to have experienced a treatment success, then that cohort will be closed and will not proceed into the 2nd stage.
Subjects will receive 200 mg of abemaciclib orally, twice a day, during cycles of 28 days each. The subject will undergo: A baseline FDG-PET/CT and a baseline CT scan and A blinded early FDG-PET/CT at D14 +/- 2 days of study treatment.
A treatment success is defined as a patient who has metabolic response according to PERCIST with a response cut off set at 15% at the early FDG-PET/CT and a morphological disease control after 2 cycles measured by RECIST v1.1.

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

85

Start Date

December 19, 2018

Completion Date

October 15, 2021

Primary Completion Date

October 15, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Age ≥ 18 years old

          2. Female or male

          3. ECOG performance status ≤ 1

          4. Life expectancy of greater than 12 weeks

          5. Must have histologically confirmed cancer corresponding to the predefined tumour
             subtypes (esophageal adenocarcinoma, esophageal squamous cell carcinoma,
             cholangiocarcinoma, urothelial cancer (progressive after immunotherapy), endometrial
             cancer) and metastatic or non-resectable and refractory to standard platinum regimens
             (and progressive after immunotherapy for the urothelial cancer).

          6. Presence of at least one metabolically measurable tumour lesion on FDG-PET/CT,
             according to PERCIST. If previously irradiated, must have been more than 2 months
             before the baseline FDG PET/CT.

          7. Measurable disease according to RECIST v 1.1

          8. Serum pregnancy test (for subjects of childbearing potential) negative

          9. Women of childbearing potential must agree to the use a highly effective method of
             contraception prior to study entry, during the course of the study and at least 3
             months after the last administration of study treatment.

         10. Men with childbearing potential partner must agree to use condom during the course of
             this study and for at least 3 months after the last administration of the study
             treatment.

         11. Adequate coagulation: International Normalized Ratio (INR) ≤ 1.5 x ULN unless subject
             is receiving anticoagulant therapy as long as INR and activated partial thromboplastin
             time [aPTT] are within therapeutic range of intended use of anticoagulants

         12. Adequate bone marrow function as defined below:

               -  Hemoglobin ≥ 10 g/dL

               -  Absolute neutrophil count ≥ 1500/µL or 1.5x109/L

               -  Platelets ≥ 100000/µL or 100x109/L

               -  Leukocytes ≥ 3,000/µL

         13. Adequate liver function as defined below:

               -  Serum total bilirubin within 1.5 × normal institutional limits (except for
                  Gilbert syndrome where direct bilirubin should be <1.5 institutional ULN)

               -  AST/ALT/ALP) levels < 3 × institutional upper limit of normal (or ALT and AST <5
                  times upper limit of normal if liver metastases are present).

         14. Adequate renal function as defined below: Cockcroft-Gault creatine clearance >50ml/min

         15. Completion of all necessary screening procedures

         16. Ability to swallow capsules

         17. Grade ≤ 1 toxicity due to any previous cancer therapy according to the National Cancer
             Institute Common Terminology Criteria of Adverse Events (NCI-CTCAE, v.4.03). Grade 2
             is allowed in case of alopecia and peripheral sensory neuropathy

         18. Availability of primary archived tumour tissue block (1 FFPE tumour tissue)

         19. Signed Informed Consent form (ICF) obtained prior to any study related procedure

        Exclusion Criteria:

          1. Subjects meeting one of the following criteria are not eligible for this
             studyParticipants who have had chemotherapy, radiotherapy, immunotherapy, or targeted
             therapy within 3 weeks prior study enrolment

          2. Participants receiving concomitantly any other experimental agents

          3. Patients who have received prior therapy with other CDK4/6 inhibitors

          4. Subjects with known brain metastasis; unless the metastasis are asymptomatic and have
             been stable since at least 2 months prior to treatment start.

          5. Patient with meningeal carcinomatosis

          6. Have had major surgery within 28 days prior to the start of the treatment to allow for
             post-operative healing of the surgical wound

          7. History of allergic reactions attributed to compounds of similar chemical or biologic
             composition

          8. Bleeding diathesis, thromboembolic event, history of cardiovascular ischemic disease
             or cerebrovascular incident within the last six months

          9. Uncontrolled concurrent illness including, but not limited to ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia

         10. Substance abuse, psychiatric illness/social situations, any psychological, familial,
             sociological, geographical condition, significant medical or surgical condition
             currently uncontrolled by treatment that would limit compliance with study
             requirements or interfere with the patient's ability to understand informed consent
             and participation in the study

         11. Pregnant and/or lactating women

         12. Uncontrolled Diabetes

         13. Known history of HIV infection, or active hepatitis B or C requiring treatment with
             anti-viral therapy

         14. Have received recent (within 28 days prior the enrolment) yellow fever vaccination

         15. Individuals with a history of a different malignancy are ineligible except for the
             following circumstances. Individuals with a history of other malignancies are eligible
             if they have been disease-free and are deemed by the investigator to be at low risk
             for recurrence of that malignancy.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Laura Polastro, MD, +3225413279, [email protected]

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT03339843

Organization ID

IJB-MULTI-MIME-A-2017


Responsible Party

Sponsor

Study Sponsor

Jules Bordet Institute

Collaborators

 Eli Lilly and Company

Study Sponsor

Laura Polastro, MD, Study Chair, Jules Bordet Institute


Verification Date

November 2018