Selinexor With Multiple Standard Chemotherapy or Immunotherapy Regimens in Treating Patients With Advanced Malignancies

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With Epithelial Ovarian Cancer VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer Liposomal Doxorubicin and Carboplatin in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Liposomal Doxorubicin and Etoposide in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer Laparoscopic Staging in Patients With Ovarian, Fallopian Tube, or Other Primary Abdominal Cancers Intraperitoneal Therapy For Ovarian 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 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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 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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

Selinexor With Multiple Standard Chemotherapy or Immunotherapy Regimens in Treating Patients With Advanced Malignancies

Official Title

Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies

Brief Summary

      This phase Ib trial studies the side effects and best dose of selinexor when given together
      with several different standard chemotherapy or immunotherapy regimens in treating patients
      with malignancies that have spread to other places in the body and usually cannot be cured or
      controlled with treatment (advanced). Selinexor may stop the growth of cancer cells by
      blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to
      stop the growth of cancer cells, either by killing the cells, by stopping them from dividing,
      or by stopping them from spreading. Studying selinexor with different standard chemotherapy
      or immunotherapy regimens may help doctors learn the side effects and best dose of selinexor
      that can be given with different types of treatments in one study.
    

Detailed Description

      PRIMARY OBJECTIVE:

      I. To establish the safety and tolerability of selinexor when given in combination with
      standard chemotherapy or immunotherapy regimens.

      SECONDARY OBJECTIVE:

      I. To determine disease control rate, objective tumor response rate, and progression free
      survival of selinexor administered with standard chemotherapy or immunotherapy treatments.

      EXPLORATORY OBJECTIVES:

      I. To determine the correlation of translational biomarkers. II. To compare serial assessment
      of mutation status in biopsies obtained at baseline and progression after clinical response
      to combination therapy.

      III. To assess the efficacy of olanzapine as incorporated in the National Comprehensive
      Cancer Network (NCCN) guidelines for the management of chemotherapy-induced nausea and
      cachexia.

      OUTLINE: This is a dose-escalation study of selinexor. Patients are assigned to 1 of 15
      treatment arms.

      ARM A: Patients receive selinexor orally (PO) on days 1, 8, and 15 and carboplatin
      intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for 6 cycles in
      the absence of disease progression or unacceptable toxicity. After 6 cycles, patients can
      continue single agent selinexor until disease progression. (ARM CLOSED)

      ARM B: Patients receive selinexor PO twice weekly (e.g. Monday/Wednesday or Tuesday/Thursday
      or Wednesday/Friday or Thursday/Saturday or Friday/Sunday) on days 1-14. Patients then
      receive selinexor PO on days 1, 3, 8 and 10 and paclitaxel IV over 3 hours on days 1 and 8.
      Treatment repeats every 21 days in the absence of disease progression or unacceptable
      toxicity. After 8 cycles, of combination treatment, patients can continue single agent
      selinexor until disease progression.

      ARM C: Patients receive selinexor PO on days 1, 8, and 15 and eribulin IV over 1 hour on days
      1 and 8. Combination treatment repeats every 21 days for 6 cycles in the absence of disease
      progression or unacceptable toxicity. After 6 cycles, patients can continue single agent
      selinexor until disease progression.

      ARM D: Patients receive selinexor PO on days 1, 8, and 15, doxorubicin IV over 90 minutes and
      cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 cycles in
      the absence of disease progression or unacceptable toxicity. After 6 cycles, patients can
      continue single agent selinexor until disease progression. (ARM CLOSED)

      ARM E: Patients receive selinexor PO on days 1, 8, and 15 and carboplatin IV over 30 minutes
      and paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for up to 8 cycles
      depending on cancer type (6 cycles for non-small cell lung cancer, up to 8 cycles for ovarian
      cancer and other histological malignancies) in the absence of disease progression or
      unacceptable toxicity. After 6 to 8 cycles, patients can continue single agent selinexor
      until disease progression. (ARM CLOSED)

      ARM F: Patients receive selinexor PO on days 1, 8, and 15 and carboplatin IV over 30 minutes
      and pemetrexed IV over 10 minutes on day 1. Treatment repeats every 21 days for 6 cycles in
      the absence of disease progression or unacceptable toxicity. After 6 cycles, patients can
      continue single agent selinexor until disease progression. (ARM CLOSED)

      ARM G: Patients receive selinexor PO on days 1, 8, and 15 and topotecan IV over 30 minutes on
      days 1-5. Treatment repeats every 21 days for 8 cycles in the absence of disease progression
      or unacceptable toxicity. After 8 cycles, patients can continue single agent selinexor until
      disease progression. (ARM CLOSED)

      ARM H: Patients receive selinexor PO on days 1, 8, 15 and 22, irinotecan hydrochloride IV
      over 90 minutes, fluorouracil continuous IV and leucovorin calcium IV over 2 hours on days 1
      and 15. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or
      unacceptable toxicity. After 6 cycles, patients can continue single agent selinexor until
      disease progression. (ARM CLOSED)

      ARM I: Patients receive selinexor PO on days 1, 8 and 15 and irinotecan hydrochloride IV over
      90 minutes on days 1 and 8. Treatment repeats every 21 days for up to 8 cycles in the absence
      of disease progression or unacceptable toxicity. After 8 cycles, patients can continue single
      agent selinexor until disease progression. (ARM CLOSED)

      ARM J: Patients receive selinexor PO on days 1, 8 and 15, capecitabine PO twice daily (BID)
      on days 1-14 and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up
      to 8 cycles in the absence of disease progression or unacceptable toxicity. After 8 cycles,
      patients can continue single agent selinexor until disease progression. (ARM CLOSED)

      ARM K: Patients receive selinexor PO on days 1, 8, 15, and 22 and olaparib PO BID on days
      1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable
      toxicity. (ARM CLOSED)

      ARM L: Patients receive selinexor PO twice weekly (e.g. Monday/Wednesday or Tuesday/Thursday
      or Wednesday/Friday or Thursday/Saturday or Friday/Sunday) and pembrolizumab IV over 30
      minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or
      unacceptable toxicity.

      ARM M: Patients receive selinexor PO twice weekly (e.g. Monday/Wednesday or Tuesday/Thursday
      or Wednesday/Friday or Thursday/Saturday or Friday/Sunday) and nivolumab IV over 30 minutes
      on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or
      unacceptable toxicity.

      ARMS N AND O: Patients receive selinexor PO on days 1, 8, and 15, nivolumab IV over 30
      minutes on day 1, and ipilimumab PO QD on day 1. Cycles repeat every 3 weeks for 4 cycles.
      Starting cycle 5, patients receive selinexor PO on days 1, 8, 15, and 22 and nivolumab IV
      over 30 minutes on day 1. Cycles repeat every 4 weeks in the absence of disease progression
      or unacceptable toxicity.

      ARM P: Patients receive selinexor PO on days 1, 8, 15, 22, 29, and 36, nivolumab IV over 30
      minutes on days 1, 15, and 29, and ipilimumab PO QD on day 1. Cycles repeat every 6 weeks in
      the absence of disease progression or unacceptable toxicity.

      Patients may continue to receive selinexor and chemotherapy after confirmed progressive
      disease in the absence of clinical deterioration and if the investigator considers that the
      patient continues to receive benefit from the treatment.

      After completion of study treatment, patients are followed up every 12 weeks for 1 year.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Incidence of adverse events

Secondary Outcome

 Disease control rate (complete response, partial response + stable disease for at least 6 months

Condition

Advanced Malignant Solid Neoplasm

Intervention

Capecitabine

Study Arms / Comparison Groups

 Arm A (selinexor, carboplatin) (ARM CLOSED)
Description:  Patients receive selinexor PO on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients can continue single agent selinexor until disease progression.

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

390

Start Date

June 26, 2015

Completion Date

December 31, 2021

Primary Completion Date

December 31, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed malignant neoplasms (not
             including hematological malignancies and brain tumors) untreated or previously treated
             requiring further treatment; patients in Arm L (pembrolizumab), Arm M (nivolumab), and
             Arms N, O, P (nivolumab and ipilimumab) that have Food and Drug Administration
             (FDA)-approved indications for nivolumab, ipilimumab, and pembrolizumab do not have to
             fail first line nivolumab, ipilimumab, or pembrolizumab, and these patients may be
             treatment naïve if they have disease where pembrolizumab or nivolumab are FDA approved
             for the first-line setting

          -  For all arms except Arm L (pembrolizumab), Arm M (nivolumab), and Arms N, O, P
             (nivolumab and ipilimumab) patients must have failed prior standard curative
             chemotherapy for their disease; subjects must have failed, be intolerant to, or be
             ineligible for any potentially curative approved treatment, irrespective of line of
             therapy

          -  Patients must have measurable disease (Response Evaluation Criteria in Solid Tumors
             [RECIST] 1.1)

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  The patient must be recovered from a prior major surgery; the major surgery must be
             performed at least 4 weeks prior to consent date

          -  Platelets >= 125 x 10^9/L (For Arm L pembrolizumab, Arm M nivolumab and Arms N, O, P
             [nivolumab and ipilimumab] and expansion cohorts for all arms, platelets >= 100 x
             10^9/L)

          -  Hemoglobin >= 10 g/dL (For Arm L pembrolizumab, Arm M nivolumab and Arms N, O, P
             [nivolumab and ipilimumab] and expansion cohorts for all arms, hemoglobin >= 9 g/dL)

          -  Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (For Arm L pembrolizumab, Arm M
             nivolumab and Arms N, O, P [nivolumab and ipilimumab], ANC >= 1.0 x 10^9/L)

          -  Transfusions and growth factors are allowed

          -  Alanine transaminase (alanine aminotransferase [ALT]) =< 2 x upper normal limit (ULN)
             (in the expansion cohort, patients with known liver involvement may have ALT =< 5 x
             ULN); aspartate aminotransferase (AST) =< 2 x ULN (in the expansion cohort, patients
             with known liver involvement may have AST =< 5 x ULN)

          -  Alkaline phosphatase < 4 x ULN

          -  Total bilirubin =< 2 x ULN (in the expansion cohort, patients with Gilbert's syndrome
             [hereditary indirect hyperbilirubinemia] who must have a total bilirubin of =< 3 x
             ULN)

          -  Renal function defined as a calculated or measured glomerular filtration rate (GFR) >=
             30 mL/min. For patients with renal cell carcinoma (RCC), the GFR may be defined as >=
             25 mL/min

          -  The patient has recovered to grade =< 1 by the National Cancer Institute Common
             Terminology Criteria for Adverse Events, version 4.03 (NCI-CTCAE v4.03) from the
             effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other
             targeted therapies, with the exception of alopecia; the exceptions for such effects
             are allowed lab values of =< grade 2 specified elsewhere in these inclusion criteria

          -  Life expectancy of at least 12 weeks

          -  Able to swallow and retain oral medication

          -  Patients must give informed consent according to the rules and regulations of the
             individual participating sites

          -  Negative serum pregnancy test in women of childbearing potential within 7 days of
             first dose of treatment and patients of child-bearing potential must agree to use
             effective contraception during/after 3 months post dose; a woman of childbearing
             potential is defined as a premenopausal female capable of becoming pregnant; this
             includes women on oral, injectable or mechanical contraception; women who are single
             and women whose male sexual partners have been vasectomized or whose male sexual
             partners have received or are utilizing mechanical contraceptive devices

          -  For the Arm B (paclitaxel) expansion cohort, patients must have ovarian carcinoma,
             fallopian tube, or peritonea carcinoma

          -  For Arm C (eribulin) expansion cohort, patients must have triple negative breast
             cancer (eribulin naive)

          -  For Arm M (nivolumab) expansion phase, patients must have biopsiable disease

          -  For the Arm N (nivolumab and ipilimumab), patients must have metastatic or
             unresectable renal cell carcinoma (RCC)

          -  For the Arm O (nivolumab and ipilimumab) escalation and expansion Cohort O-1, patients
             must have metastatic or unresectable melanoma

          -  For the Arm O (nivolumab and ipilimumab) expansion Cohort O-2, patients must have
             metastatic or advanced solid tumors (non-melanoma, non-renal cell carcinoma, or non-
             non-small cell lung carcinoma)

          -  For the Arm P (nivolumab and ipilimumab), patients must have metastatic or
             unresectable non-small cell lung carcinoma (NSCLC)

        Exclusion Criteria:

          -  Evidence of complete or partial bowel obstruction

          -  Patients with primary central nervous system (CNS) tumor or CNS tumor involvement;
             however, patients with metastatic CNS tumors may participate in this study if the
             patient is:

               -  > 4 weeks from prior therapy completion (including radiation and/or surgery)

               -  Clinically stable with respect to the CNS tumor at the time of study entry

               -  Not receiving steroid therapy in treating CNS tumor or CNS tumor involvement

               -  Not receiving anti-convulsive medications (that were started for brain
                  metastases)

          -  Need of total parenteral nutrition

          -  Prior treatment with an agent targeting the exportin

          -  Allergic to selinexor or any of the chemotherapy intended to receive

          -  Pregnancy or lactation

          -  Radiation (except planned or ongoing palliative radiation to bone outside of the
             region of measurable disease) =< 3 weeks prior to study drug administration date

          -  Chemotherapy, or immunotherapy or any other systemic anticancer therapy =< 3 weeks
             prior to study drug administration date; patients receiving anti-PD-1 treatment, and
             continue to receiving this treatment in combination with selinexor (Arms L, M, N, O,
             and P), can start receiving the selinexor and anti-PD-1 combination without washout of
             the prior anti-PD-1 antibody

          -  Diagnosis or recurrence of invasive cancer other than the present cancer within 3
             years (except basal or squamous cell carcinoma of the skin that has been definitively
             treated)

          -  Major surgery within four weeks before consent date

          -  Unstable cardiovascular function: symptomatic ischemia (chest pain of cardiac origin),
             or uncontrolled clinically significant conduction abnormalities (e.g. ventricular
             tachycardia on antiarrhythmics are excluded and 1st degree atrioventricular [AV] block
             or asymptomatic left anterior fascicular block [LAFB]/right bundle branch block [RBBB]
             will not be excluded), or congestive heart failure (CHF) of New York Heart Association
             (NYHA) class >= 3, or myocardial infarction (MI) within 3 months of consent date

          -  Uncontrolled active infection requiring parenteral antibiotics, antivirals, or
             antifungals within one week prior to the first dose; active infection with concurrent
             treatment is acceptable only if the patient is clinically stable

          -  Significantly diseased (as determined by the principal investigator [PI] or treating
             physician) or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea

          -  Treatment with an investigational anti-cancer study drug within 3 weeks prior to study
             drug administration date

          -  Concurrent therapy with approved or investigational anticancer therapeutics

          -  Medical, psychological or social conditions that may interfere with the patient's
             participation in the study or evaluation of the study results

          -  Men whose partner is a woman of child-bearing potential, (i.e. biologically able to
             conceive), and who is not employing two forms of highly effective contraception;
             highly effective contraception (e.g. male condom with spermicide, diaphragm with
             spermicide, intra-uterine device) must be used by both sexes during the study and must
             be continued for 3 months after the end of study treatment; women of child-bearing
             potential is defined as sexually mature women who are not surgically sterile or who
             have not been naturally postmenopausal for at least 12 consecutive months (e.g., who
             has had menses any time in the preceding 12 consecutive months)

          -  For Arms L (pembrolizumab) and M (nivolumab), and Arms N, O, P (nivolumab and
             ipilimumab), subjects with an active, known or suspected autoimmune disease; subjects
             with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin
             disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment,
             or conditions not expected to recur in the absence of an external trigger are
             permitted to enroll

          -  For Arms L (pembrolizumab) and M (nivolumab), and Arms N, O, P (nivolumab and
             ipilimumab), subjects receiving chronic systemic steroid therapy (in dosing exceeding
             10 mg daily of prednisone equivalent) or other form of immunosuppressive therapy
             within 7 days before the first dose of study treatment; use of inhaled or topical
             steroids or systemic corticosteroids =< 10 mg is permitted; in addition, physiologic
             steroid replacement with hydrocortisone is allowed

          -  For Arms L (pembrolizumab) and M (nivolumab), and Arms N, O, P (nivolumab and
             ipilimumab), history of a prior grade 3 or 4 immune-related adverse event (irAE) or
             any grade ocular irAE from prior immunotherapy

          -  For the Arm O (nivolumab and ipilimumab) expansion Cohort O-2, patients must not have
             melanoma, RCC, or NSCLC
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Aung Naing, 713-563-0803, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02419495

Organization ID

2014-0640

Secondary IDs

NCI-2015-00693

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Aung Naing, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

November 2021