chufangao/CTO huggingface dataset:
Clinical trial NCT04051944: A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Official title: An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 21.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-08-21
Primary completion date: 2021-11-10
Completion date: 2021-11-10
Baseline population: Baseline Characteristics refers to the Safety Set (SS) which consisted of all enrolled study participants who were administered at least one dose of rozanolixizumab in CIDP04.
Plan to share individual participant data: YES
IPD sharing description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD time frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD access criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Clinical trial NCT06297629: A Phase I/II Trial to Assess the Efficacy and Toxicity of ASTX727 (Oral Decitabine/Cedazuridine) for the Treatment of Hematological Neoplasms After Allogeneic Stem Cell Transplantation
Official title: A Phase I/II Trial to Assess the Efficacy and Toxicity of ASTX727 (Oral Decitabine/Cedazuridine) for the Treatment of Hematological Neoplasms After Allogeneic Stem Cell Transplantation
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Abandoned
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2024-07-01
Primary completion date: 2024-07-11
Completion date: 2024-07-11
Clinical trial NCT04762225: RPTR-168 in Patients With Human Papillomavirus Strain 16 (HPV-16) E6/E7 Positive Tumors and Melanoma
Official title: A Phase 1/2 Open-Label Multi-Center Study to Characterize the Safety and Tolerability of RPTR-168 in Patients With Relapsed/Refractory HPV-16 E6/E7 Positive Tumors and Melanoma
Sponsor: Repertoire Immune Medicines (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Development program terminated
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-05-10
Primary completion date: 2022-09-14
Completion date: 2022-10-11
Plan to share individual participant data: NO
Clinical trial NCT03163277: Using Less Neurotoxic Drugs in Patients With HAND (MARAND-X)
Official title: MARaviroc-based Treatment Switch in HIV-positive Patients With HAND: Consequences of Reducing Antiretroviral-associated Neurotoxicity
Acronym: (MARAND-X)
Sponsor: University of Turin, Italy (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Sloww accrual and COVID-19 related problems (impossible to perform LPs)
Enrollment: 38.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-15
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Plan to share individual participant data: NO
Clinical trial NCT02294630: Aerosolized Surfactant in Neonatal RDS
Official title: Aerosolized Survanta in Neonatal Respiratory Distress Syndrome: Phase I/II Study
Acronym: AS-02
Sponsor: Sood, Beena G., MD, MS (INDIV)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 159.0 (ACTUAL)
Number of arms: 4.0
Start date: 2014-12-31
Primary completion date: 2019-07-31
Completion date: 2020-07-31
Clinical trial NCT03498222: Study in Patients With Tumours Requiring Arginine to Assess ADI-PEG 20 With Atezolizumab, Pemetrexed and Carboplatin
Official title: Phase I Study in Patients With Tumours Requiring Arginine to Assess ADI-PEG 20 With Atezolizumab, Pemetrexed and Carboplatin (ADIAtezoPemCarbo) (iTRAP Study)
Acronym: iTRAP
Sponsor: Queen Mary University of London (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Funder and IMP manufacturer withdrew support
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-06-01
Primary completion date: 2020-01-31
Completion date: 2021-12-31
Clinical trial NCT03655821: Dose Individualization of Pemetrexed - IMPROVE-II
Official title: Individualized Pemetrexed Dosing in Patients With Non-small Cell Lung Cancer or Mesothelioma Based on Renal Function to Improve Treatment Response
Acronym: IMPROVE-II
Sponsor: Radboud University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: 81 patients included, difficult inclusion and full inclusion would not change the results
Enrollment: 81.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-01
Primary completion date: 2021-05-11
Completion date: 2021-05-11
Clinical trial NCT04596033: TiTAN-1: Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy
Official title: A Phase 1 Study to Evaluate the Safety, Proliferation and Persistence of GEN-011, an Autologous Adoptive Cell Therapy Targeting Neoantigens in Solid Tumors
Sponsor: Genocea Biosciences, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business reasons
Enrollment: 49.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-11
Primary completion date: 2022-06-27
Completion date: 2022-06-27
Clinical trial NCT05064449: A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults
Official title: A Phase 1, Open-Label Study to Evaluate the Effect of Itraconazole and Mefenamic Acid on the Single-Dose Pharmacokinetic Profile of Soticlestat in Healthy Participants
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 28.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-14
Primary completion date: 2021-11-21
Completion date: 2021-11-30
Baseline population: All participants who received at least one dose of the study drug(s) were included in the safety analysis set.
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT02586610: Trial of Chemoradiation and Pembrolizumab in Patients With Rectal Cancer
Official title: A Phase II Trial of Neoadjuvant Chemoradiation (CRT) and Pembrolizumab in Patients With Rectal Cancer: Hoosier Cancer Research Network GI15-213
Sponsor: Hoosier Cancer Research Network (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Dr. Rahma decided to run the study through a different group
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-10-31
Primary completion date: 2018-06-30
Completion date: 2020-12-31
Clinical trial NCT03523429: PETHEMA-BLIN-01/PET069014 (BLIN-01)
Official title: A Phase II, Open-label Study to Evaluate the Effect of Blinatumomab Administered During Consolidation to Reduce the Level of Minimal Residual Disease (MRD) Assessed Through Flow Cytometry in Adult Patients up to 55 Years of Age With High-risk Philadelphia Chromosome-negative (Ph-) Acute Lymphoblastic Leukaemia (ALL) With Good Response (MRD < 0.1%) After Induction Therapy
Sponsor: PETHEMA Foundation (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low rate of recruitment
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-06-30
Primary completion date: 2019-12-24
Completion date: 2022-03-09
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03862846: A Study of the Safety of REN001 in Patients With Primary Mitochondrial Myopathy
Official title: An Open-label Study to Evaluate the Safety and Tolerability of 12 Weeks Treatment With Oral REN001 in Patients With Primary Mitochondrial Myopathy (PMM), With an Optional Extension of Treatment
Sponsor: Reneo Pharma Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: COVID-19 Pandemic sufficient data gathered to achieve the study objective
Enrollment: 23.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-05-10
Primary completion date: 2020-04-23
Completion date: 2020-04-23
Clinical trial NCT05559125: A Study of STSA-1002 Combined With STSA-1005 in Healthy Subjects
Official title: An Open-label, Single-ascending Dose Phase I Study to Evaluate the Safety and Tolerability of STSA-1002 Combined With STSA-1005 in Healthy Subjects
Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.
Enrollment: 50.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-11-08
Primary completion date: 2024-03-26
Completion date: 2024-03-26
Clinical trial NCT03033316: A Evaluation of the Safety of Oncocort IV Pegylated Liposomal Dexamethasone Phosphate in Patients With Progressive Multiple Myeloma
Official title: A Phase I-IIa, Open Label, Multi-Center, Dose Escalating Study to Evaluate the Safety of Intravenous Pegylated Liposomal Dexamethasone Sodium Phosphate (Oncocort) as Monotherapy in Patients With Previously Treated Progressive Multiple Myeloma
Acronym: AMETHYST
Sponsor: Enceladus Pharmaceuticals BV (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Patient enrolment issues
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-01-31
Primary completion date: 2020-08-31
Completion date: 2020-08-31
Plan to share individual participant data: NO
Clinical trial NCT02198794: Reducing Involuntary Movements in Participants With Tardive Dyskinesia
Official title: An Open-Label, Long-Term Safety Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia
Acronym: RIM-TD
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 343.0 (ACTUAL)
Number of arms: 4.0
Start date: 2014-10-20
Primary completion date: 2019-12-06
Completion date: 2020-12-14
Baseline population: ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.)
Clinical trial NCT04125732: Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial)
Official title: A Phase 1/2 Trial of Direct Administration of AdVEGF-All6A+, a Replication Deficient Adenovirus Vector Expressing a cDNA/Genomic Hybrid of Human VEGF, to the Ischemic Myocardium of Subjects With Angina Pectoris
Acronym: EXACT
Sponsor: XyloCor Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 41.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-01-24
Primary completion date: 2023-01-31
Completion date: 2023-05-30
Plan to share individual participant data: NO
Clinical trial NCT03689712: ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
Official title: ROMAN: Reduction in Oral Mucositis With Avasopasem Manganese (GC4419) - Phase 3 Trial in Patients Receiving Chemoradiotherapy for Locally-Advanced, Non-Metastatic Head and Neck Cancer
Sponsor: Galera Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 455.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-03
Primary completion date: 2021-08-13
Completion date: 2023-08-25
Baseline population: Intent-to-Treat (ITT) population includes all randomized subjects who received at least one dose of GC4419/Placebo, with the exception of the 28 subjects whose treatment course was discontinued during the Sponsor's voluntary suspension of dosing.
Plan to share individual participant data: NO
Clinical trial NCT04197999: A Study to Determine Safety and Tolerability of GMI-1359 in Subjects With HR+ Metastatic Breast Cancer
Official title: A Phase 1b, Single and Multiple Dose, Open-Label Trial of Intravenous GMI-1359 in HR+ Metastatic Breast Cancer Subjects
Sponsor: GlycoMimetics Incorporated (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: After demonstrating the on target effect of GMI-1359 via pharmacodynamic markers (CXCR4 and E-selectin), Sponsor terminated the trial due to COVID-related slow enrollment.
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-21
Primary completion date: 2021-08-25
Completion date: 2021-08-25
Plan to share individual participant data: NO
Clinical trial NCT02855944: ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients
Official title: ARIEL4 (Assessment of Rucaparib In Ovarian CancEr TriaL): A Phase 3 Multicenter, Randomized Study of Rucaparib Versus Chemotherapy in Patients With Relapsed, BRCA Mutant, High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Sponsor: pharmaand GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 349.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-03-01
Primary completion date: 2020-12-03
Completion date: 2022-09-16
Clinical trial NCT00695786: Lenalidomide in Combination With Rituximab in Treating Participants With Stage III/IV Indolent Non-Hodgkin Lymphoma
Official title: A Phase II Study of Revlimid in Combination With Rituximab as Initial Treatment for Patients With Indolent Non-Hodgkin's Lymphoma (NHL)
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 156.0 (ACTUAL)
Number of arms: 2.0
Start date: 2008-06-10
Primary completion date: 2020-07-11
Completion date: 2020-07-11
Clinical trial NCT04847557: A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 731.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-20
Primary completion date: 2024-07-02
Completion date: 2024-07-02
Plan to share individual participant data: YES
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European (EU), whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT03395080: A Study of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial or Epithelial Ovarian Cancer or Carcinosarcoma
Official title: A Phase 2 Study Evaluating the Efficacy and Safety of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial, Epithelial Ovarian Cancer, or Carcinosarcoma
Acronym: P204
Sponsor: Leap Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 111.0 (ACTUAL)
Number of arms: 6.0
Start date: 2018-03-05
Primary completion date: 2020-09-09
Completion date: 2021-01-27
Clinical trial NCT02252432: The Effects of Ketamine and Methadone on Postoperative Pain for Laminectomy
Official title: Intraoperative Ketamine and Methadone for Laminectomy: Effect on Recovery, Postoperative Pain, and Opioid Requirements
Sponsor: Cedars-Sinai Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: No enough recruitments, very slow enrollment over the years
Enrollment: 13.0 (ACTUAL)
Number of arms: 3.0
Start date: 2013-02-28
Primary completion date: 2023-01-31
Completion date: 2023-01-31
Clinical trial NCT05463068: Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults
Official title: A Randomized, Observer-Blinded, Phase 3 Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults
Sponsor: Novavax (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 911.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-07-11
Primary completion date: 2022-08-17
Completion date: 2022-09-01
Clinical trial NCT02176863: Study of the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% DIF in Patients With Post-polio Syndrome
Official title: A Multicenter, Prospective, Randomized, Placebo-controlled, Double-blind, Parallel-group Clinical Trial to Assess the Efficacy and Safety of Immune Globulin Intravenous (Human) Flebogamma® 5% DIF in Patients With Post-Polio Syndrome
Acronym: FORCE
Sponsor: Grifols Therapeutics LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Enrollment: 191.0 (ACTUAL)
Number of arms: 5.0
Start date: 2014-09-23
Primary completion date: 2022-11-24
Completion date: 2022-11-24
Plan to share individual participant data: NO
Clinical trial NCT00085202: Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
Official title: Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
Sponsor: St. Jude Children's Research Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 416.0 (ACTUAL)
Number of arms: 2.0
Start date: 2003-08-31
Primary completion date: 2016-12-31
Completion date: 2023-12-31
Baseline population: Participants had a diagnosis of medulloblastoma, supratentorial primitive neuroectodermal tumor (PNET), PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma), or atypical teratoid rhabdoid tumor (ATRT).
Limitations and caveats: The study participants for Secondary Outcome Measure #4 were randomized to standard-of-care group vs. reading intervention after medical treatment. The participants were a subset of patients who contributed to the primary aim and who signed a separate consent form distinct from the main medical treatment consent. They were then randomly assigned to either the standard-of-care group (SOC) or to the reading intervention (RI) group.
Clinical trial NCT02833844: Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia
Official title: A Double Blind, Randomized, Placebo Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy on LDL-C of Evolocumab (AMG 145) in Subjects With HIV and With Hyperlipidemia and/or Mixed Dyslipidemia
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 467.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-22
Primary completion date: 2019-07-09
Completion date: 2020-01-27
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Clinical trial NCT02887248: Nab-paclitaxel Plus Gemcitabine as First-line Therapy for Cisplatin-ineligible or Cisplatin-incurable Advanced Urothelial Carcinoma
Official title: Phase II Study of Nanoparticle Albumin-bound Paclitaxel Plus Gemcitabine as First-line Therapy for the Treatment of Cisplatin-ineligible or Cisplatin-incurable Advanced Urothelial Carcinoma
Sponsor: SCRI Development Innovations, LLC (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Enrollment issues
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-01-12
Primary completion date: 2020-05-01
Completion date: 2020-05-01