Editing Trials (Greater Poland Cancer Centre)

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'''NCTID''': NCT02467907 
 '''Title''': Safety and Efficacy of Bevacizumab in Combination With Carboplatin and Paclitaxel for Metastatic, Recurrent or Persistent Cervical Cancer 
 '''Study Summary''': This study is to assess safety as defined by the frequency and severity of gastrointestinal (GI) perforation/fistula, GI-vaginal fistula and genitourinary (GU) fistula in participants treated with bevacizumab 15 milligrams per kilogram (mg/kg) in combination with paclitaxel and carboplatin, all repeated every 3 weeks, for recurrent, persistent or metastatic cervical cancer. In addition, this study will include evaluation of the overall safety profile of bevacizumab in combination with paclitaxel and carboplatin in this setting, assessment of GI perforation/fistula, GI-vaginal fistula and GU fistula events over time, and evaluation of efficacy. 
 '''Sponsor''': Hoffmann-La Roche 
 '''Intervention''': Bevacizumab 
 '''Start Date''': 2015-07-28 
 '''Last Updated''': 2019-06-03 
 '''Number of Patients''': 152 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Cervical Cancer 
'''NCTID''': NCT03155997 
 '''Title''': Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer 
 '''Study Summary''': The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer. 
 '''Sponsor''': Eli Lilly and Company 
 '''Intervention''': Abemaciclib 
 '''Start Date''': 2017-07-12 
 '''Last Updated''': 2023-07-14 
 '''Number of Patients''': 5637 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Breast Cancer 
'''NCTID''': NCT00911443 
 '''Title''': Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma 
 '''Study Summary''': The purpose of the study is to test safety and efficacy of different doses of thymosin alpha 1 (1.6 mg, 3.2 mg, and 6.4 mg) in combination with dacarbazine and with or without Interferon alpha in treating patients affected by stage IV melanoma.  Primary end-point is Tumor Response evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST). Secondary end-points are Overall Survival and Progression Free Survival.  Ninety-five patients are allocated to each arm to test the hypothesis that P0 &lt;= 0.05 vs the alternative hypothesis that P1 &gt;= 0.15 (alpha = 5%, within-group statistical analysis beta = 95%). 
 '''Sponsor''': sigma-tau i.f.r. S.p.A. 
 '''Intervention''': Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg 
 '''Start Date''': 2002-07 
 '''Last Updated''': 2009-07-09 
 '''Number of Patients''': 488 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Malignant Melanoma 
'''NCTID''': NCT04300647 
 '''Title''': A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer 
 '''Study Summary''': The purpose of this study is to evaluate the efficacy and safety of tiragolumab in combination with atezolizumab and atezolizumab monotherapy in patients with programmed death-ligand 1 (PD-L1)-positive cervical cancer (metastatic and/or recurrent). 
 '''Sponsor''': Hoffmann-La Roche 
 '''Intervention''': Tiragolumab 
 '''Start Date''': 2020-06-30 
 '''Last Updated''': 2023-11-18 
 '''Number of Patients''': 172 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Cervical Cancer 
'''NCTID''': NCT04209855 
 '''Title''': 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 
 '''Study Summary''': This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigator’s choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FRα) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay. 
 '''Sponsor''': ImmunoGen, Inc. 
 '''Intervention''': Mirvetuximab Soravtansine 
 '''Start Date''': 2019-12-31 
 '''Last Updated''': 2023-03-06 
 '''Number of Patients''': 453 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Epithelial Ovarian Cancer 
'''NCTID''': NCT00781612 
 '''Title''': A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies 
 '''Study Summary''': This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study. 
 '''Sponsor''': Genentech, Inc. 
 '''Intervention''': Docetaxel 
 '''Start Date''': 2008-10-16 
 '''Last Updated''': 2023-11-13 
 '''Number of Patients''': 720 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Neoplasm Metastasis 
'''NCTID''': NCT02132949 
 '''Title''': A Study Evaluating Pertuzumab (Perjeta) Combined With Trastuzumab (Herceptin) and Standard Anthracycline-based Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer 
 '''Study Summary''': This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and anthracycline-based chemotherapy as neoadjuvant treatment in participants with HER2-positive locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a treatment regimen (A or B) for all of their participants to follow. Treatment regimen A (for Cohort A) will include dose-dense doxorubicin and cyclophosphamide (ddAC), followed by paclitaxel, with pertuzumab and trastuzumab given from the start of paclitaxel. Treatment regimen B (for Cohort B) will include 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), followed by docetaxel, with pertuzumab and trastuzumab given from the start of docetaxel. Participants in both cohorts will subsequently undergo surgical treatment and then resume pertuzumab and trastuzumab treatment. 
 '''Sponsor''': Hoffmann-La Roche 
 '''Intervention''': 5-Fluorouracil 
 '''Start Date''': 2014-07-14 
 '''Last Updated''': 2021-09-17 
 '''Number of Patients''': 401 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Breast Cancer 
'''NCTID''': NCT00069745 
 '''Title''': Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen 
 '''Study Summary''': PURPOSE:  The SPARC trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and prednisone, versus prednisone alone as second line chemotherapy in patients with hormone-refractory prostate cancer (HRPC).  TARGET PATIENT POPULATION:  The SPARC trial is intended for patients who have hormone-refractory prostate cancer (HRPC) and whose disease has progressed after treatment with one chemotherapy regimen. Please refer to the Eligibility Criteria page for the key inclusion and exclusion criteria.  WHAT IS SATRAPLATIN:  Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally. Satraplatin is also the only platinum-based drug that has demonstrated efficacy against prostate cancer in a randomized trial.  RATIONALE:  There are currently no approved chemotherapy drugs for the second line treatment of hormone-refractory prostate cancer (HRPC). In a preliminary randomized trial conducted in Europe, the combination of satraplatin and prednisone had superior activity compared to prednisone alone, for the treatment of HRPC patients who had not previously been treated with chemotherapy 
 '''Sponsor''': Agennix 
 '''Intervention''': Satraplatin 
 '''Start Date''': 2003-09 
 '''Last Updated''': 2012-08-07 
 '''Number of Patients''': NA 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Prostate Cancer 
'''NCTID''': NCT05696626 
 '''Title''': Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation 
 '''Study Summary''': The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation.  The main question the study aims to answer is:  • To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day. 
 '''Sponsor''': Sermonix Pharmaceuticals Inc. 
 '''Intervention''': Lasofoxifene in combination with abemaciclib 
 '''Start Date''': 2023-10-31 
 '''Last Updated''': 2023-11-14 
 '''Number of Patients''': 400 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Metastatic Breast Cancer 
'''NCTID''': NCT04405349 
 '''Title''': Investigating the Combination of VB10.16 and Atezolizumab in Patients With HPV 16-positive Cervical Cancer 
 '''Study Summary''': This phase IIa study is designed to evaluate the safety and efficacy of multiple dosing with VB10.16 immunotherapy in combination with atezolizumab in patients with advanced or recurrent non-resectable HPV16-positive cervical cancer, who failed or are not eligible for current standard of care. 
 '''Sponsor''': Nykode Therapeutics ASA 
 '''Intervention''': VB10.16 
 '''Start Date''': 2020-07-01 
 '''Last Updated''': 2023-08-07 
 '''Number of Patients''': 50 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Cervical Cancer 
'''NCTID''': NCT04523493 
 '''Title''': Phase III Study of Toripalimab（JS001） Combined With Lenvatinib for Advanced HCC 
 '''Study Summary''': This is a prospective, randomized, placebo-controlled, double-blind, multicenter phase III registration clinical study to observe, compare and evaluate the efficacy and safety of Toripalimab combined with Lenvatinib versus placebo combined with Lenvatinib as the 1st-line therapy for advanced HCC.  Eligible subjects will be randomized at a ratio of 2:1 to receive Toripalimab combined with Lenvatinib (experimental group) or Placebo combined with Lenvatinib (control group). 
 '''Sponsor''': Shanghai Junshi Bioscience Co., Ltd. 
 '''Intervention''': Toripalimab combined with Lenvatinib 
 '''Start Date''': 2020-06-29 
 '''Last Updated''': 2023-09-13 
 '''Number of Patients''': 530 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Advanced Hepatocellular Carcinoma (HCC) 
'''NCTID''': NCT02545504 
 '''Title''': Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma 
 '''Study Summary''': The primary objective of this study is to compare the efficacy of andecaliximab (GS-5745) versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV), and oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival. 
 '''Sponsor''': Gilead Sciences 
 '''Intervention''': Andecaliximab 
 '''Start Date''': 2015-10-13 
 '''Last Updated''': 2020-05-26 
 '''Number of Patients''': 432 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Gastric Adenocarcinoma 
'''NCTID''': NCT04543617 
 '''Title''': A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy 
 '''Study Summary''': The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent chemoradiotherapy (dCRT). Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C). 
 '''Sponsor''': Hoffmann-La Roche 
 '''Intervention''': Tiragolumab 
 '''Start Date''': 2020-09-28 
 '''Last Updated''': 2023-11-03 
 '''Number of Patients''': 760 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Esophageal Squamous Cell Carcinoma 
'''NCTID''': NCT01212991 
 '''Title''': A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer 
 '''Study Summary''': The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy. 
 '''Sponsor''': Pfizer 
 '''Intervention''': Enzalutamide 
 '''Start Date''': 2010-09-16 
 '''Last Updated''': 2020-03-17 
 '''Number of Patients''': 1717 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Prostate Cancer 
'''NCTID''': NCT04177108 
 '''Title''': A Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer. 
 '''Study Summary''': This study will evaluate the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting. 
 '''Sponsor''': Hoffmann-La Roche 
 '''Intervention''': Atezolizumab 
 '''Start Date''': 2019-11-25 
 '''Last Updated''': 2023-03-23 
 '''Number of Patients''': 242 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Triple-Negative Breast Cancer 
'''NCTID''': NCT01641939 
 '''Title''': A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer 
 '''Study Summary''': This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel) treatment in participants with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. At the start of the trial (stage 1), participants will be randomized with a ratio 2:2:1 to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 milligram per kilogram (mg/kg) per intravenous injection (IV) every 3 weeks; Arm B: trastuzumab emtansine 2.4 mg/kg IV every week; Arm C: standard taxane therapy (docetaxel 75 milligram per meter square <math display="block">mg/m\^2</math> IV every 3 weeks or paclitaxel 80 mg/m^2 kg IV every week per investigator choice). At the end of the first stage of the study, the dose and schedule of trastuzumab emtansine that will be used in the second stage of the study will be selected by an Independent Data Monitoring Committee (IDMC). The regimen selection analysis will be made after approximately 100 participants across all three study arms have been treated for at least 12 weeks.  Once a trastuzumab emtansine regimen has been selected, Stage I participants who were assigned to the treatment arm which was selected for Stage II of the study and participants who were in the standard taxane group will continue to receive their assigned treatment regimen. Stage I participants who were assigned to the regimen that was not selected for further evaluation will continue to receive their assigned regimen and will continue to be followed for efficacy and safety. In Stage II of the study, additional participants will be recruited and randomized with a ratio 2:1 to either the selected regimen of trastuzumab emtansine or to the standard taxane therapy. Participants will receive study treatment until disease progression, unacceptable toxicity, initiation of another cancer therapy or withdrawal. 
 '''Sponsor''': Hoffmann-La Roche 
 '''Intervention''': Taxane 
 '''Start Date''': 2012-09-03 
 '''Last Updated''': 2017-05-12 
 '''Number of Patients''': 415 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': Gastric Cancer 
'''NCTID''': NCT01945775 
 '''Title''': A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) 
 '''Study Summary''': The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician’s choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations. 
 '''Sponsor''': Pfizer 
 '''Intervention''': talazoparib 
 '''Start Date''': 2013-10-14 
 '''Last Updated''': 2022-01-20 
 '''Number of Patients''': 431 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Breast Neoplasms 
'''NCTID''': NCT00849667 
 '''Title''': Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse 
 '''Study Summary''': This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer. 
 '''Sponsor''': Morphotek 
 '''Intervention''': Farletuzumab 
 '''Start Date''': 2009-04-16 
 '''Last Updated''': 2022-12-30 
 '''Number of Patients''': 1100 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': Ovarian Cancer 
'''NCTID''': NCT02273973 
 '''Title''': A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI) 
 '''Study Summary''': This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2 (HER2) untreated, Stage I-III operable breast cancer. Participants will be randomized into one of the two treatment arms with a 1:1 randomization ratio. Letrozole at 2.5 milligrams (mg) will be dosed once daily plus either Taselisib at 4 mg (two 2-mg tablets) or placebo on a 5 days-on/ 2 days-off schedule for a total of 16 weeks. 
 '''Sponsor''': Genentech, Inc. 
 '''Intervention''': Letrozole 
 '''Start Date''': 2014-11-12 
 '''Last Updated''': 2018-05-21 
 '''Number of Patients''': 334 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Breast Cancer 
'''NCTID''': NCT02083653 
 '''Title''': Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer 
 '''Study Summary''': This is a Phase 2, open-label, randomized, 3-arm trial investigating the efficacy of two Sym004 doses (Arm A and Arm B) compared with a control group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs). 
 '''Sponsor''': Symphogen A/S 
 '''Intervention''': Sym004 (12 mg/kg) 
 '''Start Date''': 2014-03-06 
 '''Last Updated''': 2019-04-16 
 '''Number of Patients''': 254 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Metastatic Colorectal Cancer 
'''NCTID''': NCT04634877 
 '''Title''': Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053) 
 '''Study Summary''': The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS. 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': Pembrolizumab 
 '''Start Date''': 2021-01-10 
 '''Last Updated''': 2023-11-21 
 '''Number of Patients''': 990 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Endometrial Neoplasms 
'''NCTID''': NCT00518895 
 '''Title''': Trial of Dacarbazine With or Without Genasense in Advanced Melanoma 
 '''Study Summary''': This study is being performed to prospectively determine whether dacarbazine plus Genasense is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial of dacarbazine plus Genasense. 
 '''Sponsor''': Genta Incorporated 
 '''Intervention''': dacarbazine plus Genasense 
 '''Start Date''': 2007-07 
 '''Last Updated''': 2011-11-06 
 '''Number of Patients''': 300 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Melanoma 
'''NCTID''': NCT01166542 
 '''Title''': Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers 
 '''Study Summary''': The purpose of this Phase 3 study is to evaluate overall survival and progression free survival following intravenous administration of REOLYSIN (Reovirus Serotype 3 Dearing) in combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients with metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck. 
 '''Sponsor''': Oncolytics Biotech 
 '''Intervention''': REOLYSIN 
 '''Start Date''': 2010-06 
 '''Last Updated''': 2014-11-05 
 '''Number of Patients''': 167 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Carcinoma, Squamous Cell of the Head and Neck 
'''NCTID''': NCT00069121 
 '''Title''': A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer 
 '''Study Summary''': This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals. 
 '''Sponsor''': Hoffmann-La Roche 
 '''Intervention''': Capecitabine 
 '''Start Date''': 2003-04-18 
 '''Last Updated''': 2020-03-06 
 '''Number of Patients''': 1886 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Colorectal Cancer 
'''NCTID''': NCT05067530 
 '''Title''': Cyclin dEpendent Kinase in tRiple nEGatIVe brEast canceR - a “Window of Opportunity” Study 
 '''Study Summary''': CAREGIVER is a prospective, randomized, multicenter, open, five-arm study with unequal allocation ratios of 1:1:2:1:2 (palbociclib : paclitaxel : palbociclib + paclitaxel : carboplatin : carboplatin + paclitaxel). Study will be performed in untreated patients with triple-negative breast cancer (TNBC). Potential candidates without previously established diagnosis of TNBC will be included in a Pre-screening Phase, when a biopsy of breast tumor will be taken to confirm the diagnosis of cancer, select patients with TNBC and collect tissue for translational research. 
 '''Sponsor''': Medical University of Gdansk 
 '''Intervention''': Palbociclib 
 '''Start Date''': 2022-01-01 
 '''Last Updated''': 2021-10-05 
 '''Number of Patients''': 126 
 '''Recruitment Status''': NOT_YET_RECRUITING 
 '''Condition''': Triple Negative Breast Neoplasms 
'''NCTID''': NCT03522246 
 '''Title''': A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy 
 '''Study Summary''': This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples. 
 '''Sponsor''': pharmaand GmbH 
 '''Intervention''': Rucaparib 
 '''Start Date''': 2018-05-14 
 '''Last Updated''': 2023-09-15 
 '''Number of Patients''': 1000 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Epithelial Ovarian Cancer 
'''NCTID''': NCT00530764 
 '''Title''': A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy. 
 '''Study Summary''': The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic opioid therapy. 
 '''Sponsor''': Jazz Pharmaceuticals 
 '''Intervention''': Sativex Low Dose 
 '''Start Date''': 2007-11 
 '''Last Updated''': 2013-06-20 
 '''Number of Patients''': 360 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Palliative Care 
'''NCTID''': NCT00012389 
 '''Title''': Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer 
 '''Study Summary''': RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if irinotecan is more effective with or without oxaliplatin in treating metastatic colorectal cancer.  PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with or without oxaliplatin in treating patients who have metastatic colorectal cancer. 
 '''Sponsor''': Sanofi 
 '''Intervention''': irinotecan hydrochloride 
 '''Start Date''': 2000-12 
 '''Last Updated''': 2013-12-19 
 '''Number of Patients''': NA 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Colorectal Cancer 
'''NCTID''': NCT04873362 
 '''Title''': A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy 
 '''Study Summary''': This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes. 
 '''Sponsor''': Hoffmann-La Roche 
 '''Intervention''': Atezolizumab 
 '''Start Date''': 2021-05-04 
 '''Last Updated''': 2023-11-13 
 '''Number of Patients''': 1700 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Breast Cancer 
'''NCTID''': NCT05288166 
 '''Title''': A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) 
 '''Study Summary''': The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months. 
 '''Sponsor''': Eli Lilly and Company 
 '''Intervention''': Abemaciclib 
 '''Start Date''': 2022-04-14 
 '''Last Updated''': 2023-10-19 
 '''Number of Patients''': 900 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Prostatic Neoplasms 
'''NCTID''': NCT05382286 
 '''Title''': Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer 
 '''Study Summary''': The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician’s choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1). 
 '''Sponsor''': Gilead Sciences 
 '''Intervention''': Sacituzumab Govitecan-hziy 
 '''Start Date''': 2022-07-25 
 '''Last Updated''': 2023-11-15 
 '''Number of Patients''': 440 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Triple Negative Breast Cancer 
'''NCTID''': NCT02402712 
 '''Title''': Phase IIIb Study to Evaluate the Safety and Tolerability of Herceptin SC With Perjeta and Docetaxel in Patients With HER2-positive Advanced Breast Cancer 
 '''Study Summary''': This is an open-label, single-arm, multicenter, Phase IIIb study to evaluate the safety and tolerability of Herceptin SC in combination with Perjeta IV plus docetaxel in female patients with HER2-positive metastatic or locally recurrent breast cancer. Enrolled patients are to receive study medication until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end, whichever occurs first. The anticipated time on study treatment is approximately 24 months. The target sample size is 400. 
 '''Sponsor''': Hoffmann-La Roche 
 '''Intervention''': Docetaxel 
 '''Start Date''': 2015-05-06 
 '''Last Updated''': 2019-09-06 
 '''Number of Patients''': 418 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Breast Cancer 
'''NCTID''': NCT00678392 
 '''Title''': Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer 
 '''Study Summary''': The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen. 
 '''Sponsor''': Pfizer 
 '''Intervention''': Axitinib (AG-013736) 
 '''Start Date''': 2008-09-03 
 '''Last Updated''': 2019-01-09 
 '''Number of Patients''': 723 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Kidney Neoplasms 
'''NCTID''': NCT03869892 
 '''Title''': Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy. 
 '''Study Summary''': The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab. 
 '''Sponsor''': Institut de Recherches Internationales Servier 
 '''Intervention''': Trifluridine/tipiracil hydrochloride (S95005) 
 '''Start Date''': 2019-03-21 
 '''Last Updated''': 2023-11-18 
 '''Number of Patients''': 856 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Metastatic Colorectal Cancer 
'''NCTID''': NCT03306394 
 '''Title''': A Study of Trifluridine/Tipiracil (Also Known as S 95005 or TAS-102) in Patients With a Pretreated Colorectal Cancer That Has Spread (Metastatic). 
 '''Study Summary''': The purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mCRC).  Eligible patients may receive an early access to trifluridine / tipiracil through this clinical study until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor’s prescription or can be accessed from another source or Sponsor decision. 
 '''Sponsor''': Institut de Recherches Internationales Servier 
 '''Intervention''': Trifluridine/Tipiracil hydrochloride (S95005) 
 '''Start Date''': 2016-10-18 
 '''Last Updated''': 2021-11-17 
 '''Number of Patients''': 907 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Metastatic Colorectal Cancer 
'''NCTID''': NCT03884101 
 '''Title''': Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) 
 '''Study Summary''': The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS). 
 '''Sponsor''': Merck Sharp &amp; Dohme LLC 
 '''Intervention''': Lenvatinib 
 '''Start Date''': 2019-04-11 
 '''Last Updated''': 2023-11-02 
 '''Number of Patients''': 842 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Endometrial Neoplasms 
'''NCTID''': NCT05052801 
 '''Title''': Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression 
 '''Study Summary''': The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC) 
 '''Sponsor''': Amgen 
 '''Intervention''': Bemarituzumab 
 '''Start Date''': 2022-03-07 
 '''Last Updated''': 2023-11-27 
 '''Number of Patients''': 516 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Gastric Cancer 
'''NCTID''': NCT00830180 
 '''Title''': Open Label Extension In Cancer Patients 
 '''Study Summary''': To evaluate the safety and efficacy of anti-NGF AB in cancer patients with pain due to bone metastases who participated in the double-blind Study A4091003 and who wish to receive open-label therapy. 
 '''Sponsor''': Pfizer 
 '''Intervention''': Anti-NGF AB 
 '''Start Date''': 2009-10-29 
 '''Last Updated''': 2021-04-05 
 '''Number of Patients''': 41 
 '''Recruitment Status''': COMPLETED 
 '''Condition''': Neoplasms 
'''NCTID''': NCT02771795 
 '''Title''': A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC 
 '''Study Summary''': A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC 
 '''Sponsor''': Samsung Bioepis Co., Ltd. 
 '''Intervention''': Herceptin (trastuzumab) 
 '''Start Date''': 2016-04 
 '''Last Updated''': 2021-01-07 
 '''Number of Patients''': 549 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': Breast Neoplasms 
'''NCTID''': NCT04854499 
 '''Title''': Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma 
 '''Study Summary''': The goals of this clinical study are to learn about the safety, tolerability, dosing and effectiveness of the study drug, magrolimab in combination with other anticancer therapies in patients with head and neck squamous cell carcinoma (HNSCC). 
 '''Sponsor''': Gilead Sciences 
 '''Intervention''': Magrolimab 
 '''Start Date''': 2021-09-07 
 '''Last Updated''': 2023-11-24 
 '''Number of Patients''': 230 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Head and Neck Squamous Cell Carcinoma 
'''NCTID''': NCT00412776 
 '''Title''': Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer 
 '''Study Summary''': The purpose of this study is to compare the safety and efficacy of Proxinium plus best supportive care with best supportive care only for patients with squamous cell head and neck cancer. 
 '''Sponsor''': Sesen Bio, Inc. 
 '''Intervention''': Proxinium 
 '''Start Date''': 2005-12 
 '''Last Updated''': 2015-12-23 
 '''Number of Patients''': 165 
 '''Recruitment Status''': TERMINATED 
 '''Condition''': Carcinoma, Squamous Cell of Head and Neck 
'''NCTID''': NCT05382299 
 '''Title''': Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician’s Choice in Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer 
 '''Study Summary''': The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician’s choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1. 
 '''Sponsor''': Gilead Sciences 
 '''Intervention''': Sacituzumab Govitecan-hziy 
 '''Start Date''': 2022-07-20 
 '''Last Updated''': 2023-11-15 
 '''Number of Patients''': 540 
 '''Recruitment Status''': RECRUITING 
 '''Condition''': Triple Negative Breast Cancer 
'''NCTID''': NCT05270044 
 '''Title''': Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation. 
 '''Study Summary''': The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance). 
 '''Sponsor''': Pierre Fabre Medicament 
 '''Intervention''': Encorafenib and Binimetinib 
 '''Start Date''': 2022-05-02 
 '''Last Updated''': 2023-11-22 
 '''Number of Patients''': 815 
 '''Recruitment Status''': ACTIVE_NOT_RECRUITING 
 '''Condition''': Melanoma