mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian

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Cancer With Carboplatin Trial Femara (Letrozole) Versus Placebo for Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Sorafenib and Bevacizumab to Treat Ovarian, Fallopian and Peritoneal Cancer Ixabepilone and Liposomal Doxorubicin in Advanced Ovarian Cancer SCH-58500 in Treating Patients With Primary Ovarian, Fallopian Tube, or Peritoneal Cancer (C95084) Cisplatin and Gemcitabine in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Vaccine Therapy in Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Docetaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer Carboplatin in Treating Patients With Stage IC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Monoclonal Antibody Therapy in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer S9701 Paclitaxel in Treating Patients With Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission Letrozole in Patients With Ovarian Tumors Tivozanib As Maintenance Therapy In GYN Combination Chemotherapy With or Without Whole-Body Hyperthermia in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer Low Dose Cyclophosphamide +/– Nintedanib in Advanced Ovarian Cancer Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Chemotherapy in Treating Patients With Recurrent, Metastatic, or Unresectable Ovarian, Fallopian Tube, or Peritoneal Cancer Weekly Infusions of Paclitaxel in Treating Women With Stage III or Stage IV Ovarian Cancer Refractory to Paclitaxel and Platinum Monoclonal Antibody Therapy in Treating Patients With Residual Disease From Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Following Surgery and Chemotherapy Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer Short Term Aspirin on the Biologic and Immunologic Changes of the Fallopian Tube Vaccine Therapy in Patients With Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer A Phase I Study of ABT-888 in Combination With Temozolomide in Cancer Patients Autologous T-Cells Combined With Autologous OC-DC Vaccine in Ovarian Cancer Minimally Invasive Robotic Surgery, Role in Optimal Debulking Ovarian Cancer, Recovery & Survival Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer – A Feasibility Study Proteomic Profiling in Diagnosing Ovarian Cancer in Patients Who Are Undergoing Surgery for an Abnormal Pelvic Mass Prehabilitation Care for Women With Advanced Ovarian Cancer Receiving Neoadjuvant Chemotherapy Avastin in Combination With Docetaxel in Ovarian/Fallopian Tube/Peritoneum Carcinoma Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy WCC# 59 Hyperthermic Intraperitoneal Chemotherapy Utilizing Carboplatin in First Recurrence Ovarian Cancer PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer Early Chemotherapy Based on CA 125 Level Alone Compared With Delayed Chemotherapy in Treating Patients With Recurrent Ovarian Epithelial , Fallopian Tube, or Primary Peritoneal Cancer HIPEC After Initial CRS in Patients Who Have Received NACT Study of Ramucirumab in Ovarian Cancer Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients Therapeutic Targeting of Stress Factors in Ovarian Cancer Patients Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Erlotinib and Carboplatin in Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer Bicalutamide and Goserelin in Treating Patients With Cancer of the Ovary, Fallopian Tube, or Peritoneum Vaccine Therapy in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer Capecitabine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer Paclitaxel Plus Carboplatin With or Without Topotecan in Treating Patients With Stage IIB, Stage III, or Stage IV Ovarian Epithelial Cancer A Phase II Evaluation of Dasatinib (Sprycel®, NSC #732517) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma Topotecan in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Pembrolizumab, Paclitaxel, and Carboplatin in Patients With Advanced Stage Epithelial Ovarian Cancer (EOC). Gemcitabine and Topotecan in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer Intraperitoneal vs Intravenous Chemotherapy Following Neoadjuvant Chemotherapy in Ovarian Cancer Intravital Microscopy in Evaluating Patients With Primary Peritoneal, Fallopian Tube, or Stage IA-IV Ovarian Cancer Temsirolimus in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Trial of Chemotherapy in Ovarian, Fallopian Tube and Peritoneal Carcinoma Genomic BRCA and Extensive ovArian Cancer Testing A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43) Early Post-Operative Enteral Feeding in Patients With Advanced Epithelial Ovarian Cancer EGEN-001 and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Ribociclib and Letrozole in Treating Patients With Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal, or Endometrial Cancer Trial of Tri-weekly TJ Versus Weekly TJ for Stage II-IV Mullerian Carcinoma Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer Neoadjuvant Therapy for Ovarian Cancer Neo-adjuvant Pembrolizumab in Primary Stage IV Ovarian Cancer Effect of Serotonin Level on Constipation Caused by Chemotherapy in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Carboplatin, Paclitaxel, and Surgery in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Intraperitoneal Paclitaxel and Carboplatin With IV Avastin Therapy in Patients With Carcinomas of Mullerian Origin 18F-CP18 Imaging Studies for Cancer Treatment With Birinapant Phase 2, A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy Bevacizumab Study With Carboplatin & Paclitaxel in Ovarian, Fallopian Tube or Primary Peritoneal Cancer Lurtotecan Liposome in Treating Patients With Advanced or Recurrent Ovarian Epithelial Cancer Depression Treatment and Screening in Ovarian Cancer Patients Effect of Acetylcysteine With Topotecan Hydrochloride on the Tumor Microenvironment in Patients With Persistent or Recurrent High Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel Bevacizumab for Primary Ovarian Bevacizumab and Erlotinib in Treating Patients With Recurrent or Metastatic Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Alimta® Plus Cisplatin & Paclitaxel Given Intraperitonelly; First Line Tx Stage III Ovarian Cancer Anti—PD-L1 and SAbR for Ovarian Cancer Autologous OC-L Vaccine and Ovarian Cancer S9912 Combination Chemo in Stage III Ovarian Cancer, Study of Paclitaxel in Patients With Ovarian Cancer Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Rilotumumab in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Retrospective Case Study to Validate Existing Chemoresponse Marker Test in Ovarian, Peritoneal or Fallopian Cancer Cases TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian Ph II Atrasentan + DOXIL in Recurrent Ovarian/Fallopian/Peritoneal Serous Papillary Adenocarcinoma PDL-1 Inhibition and Focal Sensitizing Radiotherapy in Recurrent Ovarian/Primary Peritoneal/Fallopian Tube Cancers. Guadecitabine and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Belinostat and Carboplatin in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Carboplatin or Cisplatin Veliparib and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer or Metastatic Breast Cancer A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer A Trial of Intravenous Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A in Stage III or IV Ovarian Cancer A6 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Olaparib and Cediranib Maleate in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Physical Activity Monitored by Fitbit Charge 2 in Improving Quality of Life in Participants With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Denileukin Diftitox Used in Treating Patients With Advanced Refractory Ovarian Cancer, Primary Peritoneal Carcinoma, or Epithelial Fallopian Tube Cancer RO4929097 in Treating Patients With Recurrent and/or Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Vaccine Therapy and Cyclophosphamide in Treating Patients With Stage II-III Breast or Stage II-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer Carboxyamidotriazole in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Vinorelbine in Relapsed Platinum Resistant or Refractory C5 High Grade Serous, Endometrioid, or Undifferentiated Primary Peritoneum, Fallopian Tube or Ovarian Cancer Durvalumab and Tremelimumab in Treating Participants With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer OPT-821 With or Without Vaccine Therapy in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in Second or Third Complete Remission Docetaxel Plus Carboplatin in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Study of Birinapant in Combination With Conatumumab in Subjects With Relapsed Ovarian Cancer Symptom Management in Patients With Recurrent or Persistent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer Genetically Modified T Cells and Decitabine in Treating Patients With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Decitabine, Vaccine Therapy, and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer Study of Prolanta™ in Recurrent or Persistent Epithelial Ovarian Cancer A Phase 1b Study of OMP-305B83 Plus Paclitaxel in Subjects With Ovarian, Peritoneal or Fallopian Tube Cancer Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer S0009 Combination Chemo and Surgery in Stage III or Stage IV Ovarian Cancer EGEN-001 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Adavosertib With or Without Olaparib in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Combination Chemotherapy in Treating Patients With Untreated Ovarian, Peritoneal, or Fallopian Tube Cancer Sorafenib in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in at Least the Second Remission Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer Phase II ABT-888 With Cyclophosphamide PD 0360324 and Cyclophosphamide in Treating Patients With Recurrent High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Bevacizumab With or Without Everolimus in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Auranofin in Treating Patients With Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer AMG 386 (Trebananib) in Ovarian Cancer (TRINOVA-2) Docetaxel With or Without Phenoxodiol in Treating Patients With Recurrent Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer Taurolidine in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Combination Chemotherapy and Autologous Peripheral Stem Cell Transplant in Treating Patients With Stage III, Stage IV, or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Topotecan Plus Etoposide in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Photoacoustic Imaging in Detecting Ovarian or Fallopian Tube Cancer Phase 2 Study of Pembrolizumab, DPX-Survivac Vaccine and Cyclophosphamide in Advanced Ovarian, Primary Peritoneal or Fallopian Tube Cancer UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Biomarkers in Predicting Response in Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Treated on GOG-0172 or GOG-0182 Laboratory Study in Predicting Tumor Response to Chemotherapy in Patients With Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer CA 125 Levels in Treating Patients With Relapsed Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Who Are Receiving Tamoxifen Pazopanib Hydrochloride, Paclitaxel, and Carboplatin in Treating Patients With Refractory or Resistant Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer Liposome-Encapsulated Doxorubicin Citrate With or Without Gemcitabine Hydrochloride in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Carboplatin With or Without Decitabine in Treating Patients With Progressive, Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer S0904: Docetaxel With or Without Vandetanib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Vaccine Therapy and OPT-821 or OPT-821 Alone in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer in Complete Remission Lenalidomide and Doxorubicin Hydrochloride Liposome in Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Dose-Escalation Study of Intraperitoneal (IP) Cisplatin, IV/IP Paclitaxel, IV Bevacizumab, and Oral Olaparib for Newly Diagnosed Ovarian, Primary Peritoneal, and Fallopian Tube Cancer Bortezomib and Carboplatin in Treating Patients With Recurrent or Progressive Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Intraperitoneal Infusion of Autologous Monocytes With Sylatron (Peginterferon Alfa-2b) and Actimmune (Interferon Gamma-1b) in Women With Recurrent or Refractory Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer Study of Mirvetuximab Soravtansine in Comb. With Bevacizumab, Carboplatin, PLD, Pembrolizumab, or Bevacizumab + Carboplatin in Adults With FRa + Adv. EOC, Primary Peritoneal or Fallopian Tube Cancer AMG 706 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Oxaliplatin and Topotecan in Treating Patients With Previously Treated Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer Paclitaxel + Carboplatin With AVB-S6-500 in Women With Stage III or IV Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Receiving Neoadjuvant Chemotherapy ZD9331 With or Without Topotecan in Treating Patients With Refractory or Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer UCN-01 and Topotecan in Treating Patients With Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer Homologous Recombination Inquiry Through Ovarian Malignancy Investigations Study of AMG 386 in Combination With Paclitaxel and Carboplatin in Subjects With Ovarian Cancer CT-2103 in Treating Patients With Recurrent Ovarian Epithelial or Fallopian Tube Cancer or Primary Peritoneal Cancer Avastin in Patients With Epithelial Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer Gene Therapy in Treating Women With Refractory or Relapsed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer Trial of Best Supportive Care and Either Cisplatin or Paclitaxel to Treat Patients With Primary Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer and Inoperable Malignant Bowel Obstruction Pegylated Liposomal Doxorubicin Hydrochloride, Carboplatin, Veliparib, and Bevacizumab in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Correlation of the Chemoresponse Assay With PFS in Patients With Recurrent Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer Carboplatin/Paclitaxel +/-Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer Mifepristone in Treating Patients With Recurrent or Persistent Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Sargramostim and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Previous Chemotherapy Paclitaxel, Bevacizumab And Adjuvant Intraperitoneal Carboplatin in Treating Patients Who Had Initial Debulking Surgery for Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Carboplatin, Gemcitabine Hydrochloride, and ATR Kinase Inhibitor VX-970 in Treating Patients With Recurrent and Metastatic Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer Intravenous and Intraperitoneal Paclitaxel, Intraperitoneal Cisplatin, and Intravenous Bevacizumab for the Initial Treatment of Optimal Stage II or III Ovarian, Primary Peritoneal, and Fallopian Tube Cancer PH3 Study of Mirvetuximab Soravtansine vs Investigator’s Choice of Chemotherapy in Women With FRa+ Adv. EOC, Primary Peritoneal or Fallopian Tube Cancer Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer AZD2171 in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer Avatar-Directed Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Nivolumab With or Without Ipilimumab in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Sorafenib With or Without Paclitaxel and Carboplatin in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Gemcitabine Hydrochloride Alone or With M6620 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer A Study of Mirvetuximab Soravtansine in Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression A Clinical Study of Gimatecan in Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer Pemetrexed Disodium and Carboplatin in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Viral Therapy in Treating Patients With Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Did Not Respond to Platinum Chemotherapy SJG-136 in Treating Patients With Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer That Did Not Respond to Previous Treatment With Cisplatin or Carboplatin A Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression A Phase II Study of ZD1839 and Tamoxifen in Patients With Epithelial Ovarian Carcinoma, Cancer of the Fallopian Tube or the Peritoneum Refractory to Platinum- and Taxane-based Therapy Erlotinib, Docetaxel, and Carboplatin in Treating Patients With Newly Diagnosed Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer TRINOVA-1: A Study of AMG 386 or Placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer A Study to Evaluate rhuMab 2C4 and Gemcitabine in Subjects With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Cediranib Maleate in Treating Patients With Persistent, Recurrent, or Refractory Advanced Ovarian Epithelial, Peritoneal Cavity, or Fallopian Tube Cancer Topotecan and Gefitinib (Iressa) for Ovarian, Peritoneal, or Fallopian Tube Cancer Combination Chemotherapy Consisting of Gemcitabine And Topotecan in Treating Patients With Refractory or Recurrent Ovarian or Fallopian Tube Cancer VEGF Trap and Docetaxel in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer Phase 2 Trial of Regorafenib in Patients With Recurrent Ovarian, Primary Peritoneal and Fallopian Tube Cancer Predictors of Relapse of Ovarian, Peritoneal, and Fallopian Tube Cancers Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer p53 Gene in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer S0025 Irinotecan in Treating Patients With Refractory Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer Safety Study Involving Oxaliplatin With Docetaxel for Recurrent Ovarian,Primary Peritoneal, and Fallopian Tube Cancer PEG-Interferon Alfa-2b in Treating Patients With Platinum-Resistant Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer Hu3S193 in Treating Women With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer CP-547,632 in Treating Patients With Recurrent or Persistent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Gemcitabine and Carboplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer That Responded to Previous Cisplatin or Carboplatin A Phase II Combined Modality Protocol of Debulking Surgery With HIPEC Followed by Intraperitoneal Chemotherapy for the Treatment of Recurrent Ovarian, Primary Peritoneal & Fallopian Tube Cancers Role of Spirituality in Coping and Surviving With Ovarian Cancer, Primary Peritoneal or Fallopian Tube Cancer

Brief Title

mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian

Official Title

A Phase Ib Study of the Oral PARP Inhibitor Olaparib With the Oral mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial, Triple Negative Breast, and Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Brief Summary

      This phase Ib/II trial studies the side effects and best dose of olaparib and vistusertib
      (AZD2014) or olaparib and capivasertib (AZD5363) when given together in treating patients
      with endometrial, triple negative breast cancer, ovarian, primary peritoneal, or fallopian
      tube cancer that has come back (recurrent). Olaparib, vistusertib, and capivasertib may stop
      the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of
      the combinations of AZD2014 + olaparib and confirmation of recommended phase 2 dose (RP2D)
      for the AZD5363 + olaparib combination in patients with recurrent endometrial, recurrent
      triple negative breast, recurrent high-grade serous ovarian, or recurrent breast cancer, BRCA
      mutant ovarian cancer.

      SECONDARY OBJECTIVES:

      I. To determine the tolerability of the RP2D of AZD2014 + olaparib and AZD5363 + olaparib.

      II. To determine the safety and observed toxicities of the combination of AZD2014 + olaparib
      and AZD5363 + olaparib in patients with recurrent endometrial, recurrent triple negative
      breast, recurrent high-grade serous ovarian, or BRCA mutant ovarian cancer.

      III. To estimate the activity of these drug combinations at all dose levels in each patient
      cohort by objective response rate and proportion of patients surviving progression free (PFS)
      at 6 months.

      IV. To determine response duration of these combinations at all dose levels. V. To determine
      the pharmacokinetics (PK) of each agent alone and in combination to assess the presence of
      any drug interaction between the two co-administered agents.

      EXPLORATORY TRANSLATIONAL OBJECTIVES:

      I. To determine if response to therapy is associated with molecular profile of the tumor
      (including, but not limited to, molecular aberrations in the phosphoinositide-3-kinase
      [PI3K]- v-akt murine thymoma viral oncogene homolog [AKT]- mechanistic target of rapamycin
      [mTOR] pathway or defects in homologous recombination) before treatment.

      II. To examine associations with early changes in functional proteomic biomarkers in tumor
      biopsies before and after treatment and tumor response in patients with recurrent
      endometrial, recurrent triple negative breast, recurrent high-grade serous ovarian, or BRCA
      mutant ovarian cancer treated with the investigational agents.

      III. To determine the molecular profile of unusual responders (significant regression of
      disease or progression of disease).

      IV. To provide data to investigate the relationship between plasma concentrations/exposure
      and changes in safety and efficacy outputs to facilitate population analysis by sponsor.

      OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 3 treatment arms.

      ARM I (CONTINUOUS AZD2014 DOSING): Patients receive olaparib orally (PO) twice daily (BID) on
      days 1-28 (days 5-28 of course 1 and alone on days -3 to -1 of week -1) and vistusertib PO
      BID on days 1-28 (alone on days 1-4 of week 1).

      ARM II (INTERMITTENT AZD2014 DOSING): Patients receive olaparib PO BID on days 1-28 (days
      3-28 on course 1 and alone on days -5 to -3 of week -1) and vistusertib PO BID for 2 days on
      and 5 days off (alone on days 1-2 of week 1).

      ARM III (INTERMITTENT AZD5363 DOSING): Patients receive olaparib PO BID on days 1-28 (on days
      5-28 of course 1 and alone on days -3 to -1 of week -1) and capivasertib PO BID for 4 days on
      and 3 days off (alone on days 1-4 of week 1).

      In all arms, courses repeat every 28 days in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed up within 4 weeks.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Maximum tolerated dose

Secondary Outcome

 Toxicity profile, including dose-limiting toxicities

Condition

BRCA1 Mutation Carrier

Intervention

Capivasertib

Study Arms / Comparison Groups

 Arm I (olaparib, vistusertib)
Description:  CONTINUOUS AZD2014 DOSING: Patients receive olaparib PO BID on days 1-28 (days 5-28 of course 1 and alone on days -3 to -1 of week -1) and vistusertib PO BID on days 1-28 (alone on days 1-4 of week 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

159

Start Date

November 11, 2014

Completion Date

November 30, 2021

Primary Completion Date

November 30, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Any histologically confirmed locally advanced recurrent endometrial adenocarcinoma
             (except for carcinosarcoma), recurrent high-grade serous ovarian/primary
             peritoneal/fallopian tube carcinoma, or deleterious BRCA mutant recurrent
             ovarian/primary peritoneal/fallopian tube cancer for whom no curative option is
             available will be eligible; any patient proven to have metastatic triple negative
             breast cancer, defined from standard pathologic assays as negative for estrogen
             receptor (ER) and progesterone receptor (PR) (< 10% tumor staining) will be eligible

          -  Patients may have unlimited prior chemotherapeutic regimens for management of
             recurrent locally advanced endometrial carcinoma, recurrent ovarian carcinoma, or
             metastatic triple negative breast cancer; treatment as frontline therapy for
             metastatic disease is acceptable; patients who have received prior PARP inhibitors,
             MTOR inhibitors, and/or AKT inhibitors are allowed to participate; patients may have
             progressed on prior PARP inhibitor, MTOR inhibitor, or AKT inhibitor but they may not
             have discontinued drug for toxicity

          -  With the exception of alopecia, any unresolved toxicities from prior chemotherapy
             should be no greater than Common Terminology Criteria for Adverse Events (CTCAE)
             (version 4.0) grade 1 at the time of starting study treatment

          -  Patients should have measurable disease as defined by Response Evaluation Criteria in
             Solid Tumors (RECIST) 1.1; if no measurable disease is present, patients should have
             assessable disease such as pleural effusion, ascites, with cancer antigen 125 (CA125)
             Gynecological Cancer Intergroup (GCIG) criteria

          -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
             0 or 1

          -  Women of child-bearing potential and their partners must agree to use contraception
             (hormonal or barrier method of birth control; abstinence) from study entry until 30
             days after last dose of study drug; male partners should be instructed to use
             contraception during the study period; women of child-bearing potential (intact
             uterus) should have a negative serum pregnancy test; if a woman becomes pregnant or
             suspects she is pregnant while on study, she should tell her treating physician
             immediately; female patients must have evidence of non-child-bearing potential by
             fulfilling 1 of the following at screening: a) post-menopausal defined as > 50 years
             old and amenorrheic for >= 12 consecutive months following cessation of all exogenous
             hormonal treatments; b) documentation of irreversible surgical sterilization by
             hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal
             ligation

          -  Women must not breast-feed while taking the study medications

          -  Absolute neutrophil count >= 1,500/mcL (measured within 28 days prior to
             entry/randomization)

          -  Hemoglobin >= 10 gm/dL (measured within 28 days prior to entry/randomization)

          -  Platelets >= 100,000/mcL (measured within 28 days prior to entry/randomization)

          -  Presence of < 4% blasts on hematologic studies (measured within 28 days prior to
             entry/randomization)

          -  Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (measured within 28
             days prior to entry/randomization)

          -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit
             of normal unless the liver is involved with tumor, in that case, ALT/AST must be =< 5
             x ULN (measured within 28 days prior to entry/randomization)

          -  Creatinine clearance > 50 mL/min (assessed by Cockcroft Gault estimation) (measured
             within 28 days prior to entry/randomization)

          -  Patients with type II diabetes mellitus that is well controlled by dietary measures
             alone and have a hemoglobin A1c (HgA1c) < 8% are eligible to participate; patients
             found to have a fasting glucose >= 7 mmol/L (>= 126 mg/dL) or glycosylated hemoglobin
             > 8% (64 mmol/mol) at screening should be assessed for appropriate management
             according to local policy; those in whom dietary measures alone provide good diabetic
             control will be eligible for inclusion; type I or II diabetes mellitus requiring
             either insulin or oral hypoglycemics for routine management will be excluded

          -  Patients must be able to swallow and tolerate oral medications and not have
             gastrointestinal illnesses that would preclude absorption of AZD2014, AZD5363, or
             olaparib (e.g. uncontrolled nausea, vomiting, or diarrhea; malabsorption syndrome;
             ulcerative disease)

          -  Participants' life expectancy must be > 4 months

          -  Patients must be able to understand and willing to sign an informed consent

          -  FOR EXPANSION PHASE ONLY: For the expansion phase, patients must have measurable
             disease accessible for biopsy

          -  FOR EXPANSION PHASE ONLY: For the expansion phase, patients must have archival
             specimens from the time of primary or recurrence diagnosis

        Exclusion Criteria:

          -  Patients receiving any other investigational agents or any additional anti-cancer
             agents

          -  Patients who have endometrial carcinosarcoma; patients with ovarian cancer who have
             histology other than high-grade serous in the absence of a deleterious BRCA mutation;
             if the patient has a deleterious BRCA mutation, any histology will be accepted

          -  Patients who have recurrences that are amenable to potentially curative treatment with
             radiation therapy or surgery

          -  Patients who have a history of other malignancies except for basal cell or squamous
             cell skin cancer, in situ cervical cancer, unless they have been disease-free for at
             least five years; patients may have dual primaries of endometrial, ovarian or breast
             cancer

          -  Patients who have a history of myelodysplastic syndrome

          -  Patients who have symptomatic, uncontrolled spinal cord compression and/or brain
             metastases; a scan to confirm absence of brain metastasis is not required; patients
             can receive a stable dose of corticosteroids (except those prohibited per protocol)
             before/during study if these were started at least 28 days prior to entry

          -  Patients who have had prior chemotherapy, biological therapy, radiation therapy,
             androgens, thalidomide, immunotherapy, other anticancer agents, and any
             investigational agents within 28 days of starting study treatment (not including
             palliative radiotherapy at focal sites), or corticosteroids that are prohibited per
             protocol within 14 days of starting study treatment

          -  Patients who have had major surgery within 28 days prior to entry into the study or be
             recovering from any effects of surgery; patients who have had minor surgery within 2
             weeks prior to entry into the study

          -  Patients who have a resting electrocardiogram (ECG) with a Fridericia corrected QT
             (QTcF) interval of >= 470 msec at 2 or more time points within a 24 hour period or a
             family history of long QT syndrome

          -  Patients who have required a blood transfusion within 28 days prior to study start

          -  Patients who have received any hemopoietic growth factors (e.g., filgrastim [G-CSF],
             sargramostim [GM-CSF]) within 2 weeks prior to study start

          -  Patients receiving certain medications and/or substances that are prohibited within
             stated wash-out periods

          -  Patients with known hypersensitivity to olaparib, AZD5363, AZD2014 or any of their
             excipients; patients with a history of hypersensitivity to drugs with a similar
             chemical structure or class to olaparib, AZD5363, or AZD2014

          -  Patients who have experienced intolerable adverse events per treating investigator due
             to other PARP inhibitors, mTOR inhibitors, PI3 kinase inhibitors, or AKT inhibitors

          -  Patients who have experienced any of the following procedures or conditions currently
             or in the preceding 12 months: a) coronary artery bypass graft; b) angioplasty; c)
             vascular stent; d) myocardial infarction; e) angina pectoris; f) congestive heart
             failure New York Heart Association grade >= 2; g) ventricular arrhythmias requiring
             continuous therapy; h) supraventricular arrhythmias including atrial fibrillation,
             which are uncontrolled; i) hemorrhagic or thrombotic stroke, including transient
             ischemic attacks or any other central nervous system bleeding

          -  Patients who have abnormal echocardiogram (ECHO) or multi-gated acquisition scan
             (MUGA) at baseline (left ventricular ejection fraction [LVEF] < 50%); appropriate
             correction to be used if a MUGA is performed

          -  Patients with torsades de pointes within 12 months of study entry

          -  Patients with uncontrolled hypotension (systolic blood pressure < 90 mmHg and/or
             diastolic blood pressure < 50 mmHg)

          -  Patients with proteinuria (3+ on dipstick or 300 mg/dL on urine analysis or > 500
             mg/dL/24 hours)

          -  Patients with diabetes type I or uncontrolled type II (HbA1c > 8 % assessed locally)
             as judged by the investigator

          -  As judged by the investigator, any evidence of severe or uncontrolled systemic
             diseases (e.g., severe hepatic impairment, interstitial lung disease [bilateral,
             diffuse, parenchymal lung disease], uncontrolled chronic renal diseases
             [glomerulonephritis, nephritic syndrome, Fanconi syndrome or renal tubular acidosis]),
             or current unstable or uncompensated respiratory or cardiac conditions, or
             uncontrolled hypertension (blood pressure >= 140/90), active bleeding diatheses or
             active infection including hepatitis B, hepatitis C, and human immunodeficiency virus;
             screening for chronic conditions is not required

          -  As judged by the investigator, the patient is unsuitable to participate in the study
             and the patient is unlikely to comply with study procedures, restrictions, and
             requirements

          -  FOR EXPANSION PHASE ONLY: Lack of accessible tumor for biopsy

          -  Lack of archival specimens from the time of primary or recurrence diagnosis
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Shannon N Westin, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02208375

Organization ID

2013-0784

Secondary IDs

NCI-2014-01973

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Shannon N Westin, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

July 2020