chufangao/CTO huggingface dataset:
Clinical trial NCT01968213: Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3)
Official title: 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 ( ARIEL3 )
Acronym: ARIEL3
Sponsor: pharmaand GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 564.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-04-07
Primary completion date: 2017-04-01
Completion date: 2022-07-07
Clinical trial NCT05105412: Lenalidomide and Gemcitabine in Relapsed or Refractory Peripheral T-cell Lymphomas
Official title: A Single Arm，Phase Ib/II Study of the Combination of Lenalidomide and Gemcitabine in Relapsed or Refractory Peripheral T-cell Lymphomas (PTCL)
Sponsor: National Health Research Institutes, Taiwan (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The resolution of DSMB
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-06-15
Primary completion date: 2024-03-30
Completion date: 2024-03-30
Clinical trial NCT04370834: Tocilizumab for Patients With Cancer and COVID-19 Disease
Official title: Tocilizumab in Hospitalized Cancer Patients With Coronavirus 2019 (SARS-CoV-2) and Severe Complications of Coronavirus Disease 19 (COVID-19)
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Other - Randomized data no longer support continuation
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-05-28
Primary completion date: 2021-01-14
Completion date: 2021-01-14
Limitations and caveats: Early termination as randomized data did not support continuation.
Plan to share individual participant data: YES
IPD sharing description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Clinical trial NCT03926195: Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis
Official title: A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis
Acronym: MANTA-RAy
Sponsor: Galapagos NV (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 109.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-28
Primary completion date: 2020-08-14
Completion date: 2023-05-10
Baseline population: The Safety Analysis Set included all randomized participants who took ≥ 1 dose of double-blind study drug.
Plan to share individual participant data: NO
Clinical trial NCT04513067: A Safety Study of YQ23 in Advanced Solid Tumors Patients
Official title: A Phase Ib, Open-label, Dose-escalation Study of YQ23 as a Single Agent and in Combination With Pembrolizumab Administered to Patients With Advanced Solid Tumors
Sponsor: New Beta Innovation Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to business decision
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-21
Primary completion date: 2023-07-26
Completion date: 2023-07-26
Plan to share individual participant data: NO
Clinical trial NCT03741712: A Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of mCRPC
Official title: A Phase I/II,Open-Label,Does-Escalation and -Expansion, Safety,Pharmacokinetics and Efficacy Study of SHR2554 Alone or in Combination With SHR3680 in the Treatment of Patients With Metastatic Castration Resistant Prostate Cancer
Sponsor: Jiangsu HengRui Medicine Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: According to the available data from the trial，the sponsor determined to terminate this study.
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-20
Primary completion date: 2019-09-30
Completion date: 2020-12-08
Clinical trial NCT04933968: Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant
Official title: Phase 1/2, Double-Blind, Placebo-Controlled, Dose Escalation and Expansion Study of ALVR106 in Addition to Standard of Care for the Treatment of High-Risk Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant
Sponsor: AlloVir (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Strategic sponsor decision
Enrollment: 17.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-21
Primary completion date: 2024-01-31
Completion date: 2024-01-31
Baseline population: The modified intent-to-treat population for Part A which included all randomized participants who received any amount of ALVR106 or placebo and had confirmed virologic infection of interest at baseline (detectable viral load). One participant randomized to the placebo cohort did not receive study treatment and is not included. Due to early study termination, no participants were enrolled into Part B and therefore Part B is not included in the baseline analysis population.
Limitations and caveats: Results are included for Part A only as no participants were enrolled into Part B due to early study termination.
Clinical trial NCT03151811: A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide
Official title: A Randomized, Controlled, Open-label, Phase 3 Study of Melflufen/Dexamethasone Compared With Pomalidomide/Dexamethasone for Patients With Relapsed Refractory Multiple Myeloma Who Are Refractory to Lenalidomide
Acronym: OCEAN
Sponsor: Oncopeptides AB (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor assessed all endpoints and collected Overall Survival data for another two years following the primary completion date of 03Feb2021.
Enrollment: 495.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-12
Primary completion date: 2021-02-03
Completion date: 2023-02-03
Baseline population: All patients that were enrolled defined as patients assigned a unique patient number by Interactive Response Technology system at the time of enrollment.
Plan to share individual participant data: NO
Clinical trial NCT04964557: A Study to Assess the Safety, Efficacy and Tolerability of AZD8233 Treatment in Participants With Hyperlipidaemia
Official title: A Randomised, Parallel, Double-Blind, Placebo-Controlled Phase 2b Study to Assess the Safety, Tolerability and Efficacy of AZD8233 Treatment in Participants With Hyperlipidaemia
Acronym: SOLANO
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 411.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-07
Primary completion date: 2022-07-15
Completion date: 2022-07-15
Baseline population: Baseline analysis population is based on the Full analysis set (FAS) which includes all subjects who were randomly assigned to study intervention. Subjects were analysed according to their randomised study medication assignment, irrespective of the treatment actually received. Number Started in the Participant Flow is the number of subjects who were randomised.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT03285607: MCS110 Combined With Neoadjuvant Doxorubicin, Cyclophosphamide, and Weekly Paclitaxel in Patients With Hormone-Receptor Positive and HER2- Breast Cancer
Official title: Phase I Study of MCS110 Combined With Neoadjuvant Dose-Dense Doxorubicin, Cyclophosphamide, and Weekly Paclitaxel in Patients With Hormone-Receptor Positive and HER2- Breast Cancer
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Drug provider decided not to move forward with the study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-09-30
Primary completion date: 2019-10-31
Completion date: 2021-02-28
Plan to share individual participant data: NO
Clinical trial NCT04423757: A Home-based Study Using Mobile Technology to Test Whether BI 1358894 is Effective in People With Depression
Official title: A Phase II 6-week, Randomized, Double-blinded, Placebo Controlled, Parallel Group Decentralised Clinical Trial to Evaluate Efficacy and Safety of Oral BI 1358894 in Patients With Major Depressive Disorder With Inadequate Response to Antidepressants
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Recruitment challenges
Enrollment: 45.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-22
Primary completion date: 2022-04-19
Completion date: 2022-05-08
Baseline population: Treated Set (TS): all subjects who were randomized and received at least one administration of study drug.
Limitations and caveats: Results should be interpreted in a descriptive manner since the trial was terminated early and the specified number of patients required for the analyses was not obtained.
Plan to share individual participant data: YES
IPD sharing description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.
IPD time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Clinical trial NCT04791514: A Study of Treprostinil Palmitil Inhalation Powder (TPIP) In Pulmonary Arterial Hypertension (PAH)
Official title: An Open-Label Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension
Sponsor: Insmed Incorporated (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low enrolment
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-03-29
Primary completion date: 2022-08-26
Completion date: 2022-08-26
Baseline population: The study was terminated by the Sponsor due to low enrolment. As only 1 participant was enrolled in this study, no data is reported here, in order to protect and maintain participant privacy/confidentiality.
Limitations and caveats: The study was terminated by the Sponsor due to low enrolment. As only 1 participant was enrolled in this study, no data is reported here, in order to protect and maintain participant privacy/confidentiality.
Plan to share individual participant data: NO
Clinical trial NCT04990778: Venetoclax and Eprenetapopt for the Treatment of Relapsed of Refractory Mantle Cell Lymphoma
Official title: An Open Label, Phase II Investigator-Initiated Study of Venetoclax and Eprenetapopt (APR-246) in Previously Treated Relapsed/Refractory Patients With Mantle Cell Lymphoma (MCL)
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: PI Request
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-11-30
Primary completion date: 2023-03-24
Completion date: 2023-03-24
Clinical trial NCT02435095: Antipsychotic Induced Structural and Functional Brain Changes
Official title: Are Antipsychotics Neurotoxic or Neuroprotective? A Long-term Comparison of Two Treatment Strategies
Acronym: APIC
Sponsor: RWTH Aachen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: slow patient recruitment, low patient-commpliance, high dropout rates,
Enrollment: 174.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-05-31
Primary completion date: 2020-08-31
Completion date: 2020-08-31
Clinical trial NCT03445533: A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma
Official title: A Randomized Phase 3 Comparison of IMO-2125 With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)
Sponsor: Idera Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Lack of Efficacy
Enrollment: 481.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-05-30
Primary completion date: 2021-06-01
Completion date: 2021-06-01
Plan to share individual participant data: NO
Clinical trial NCT03449030: A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC)
Official title: An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-164, an Antibody-Drug Conjugate, in Patients With Advanced Gastrointestinal Cancers Expressing Guanylyl Cyclase C
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Insufficient clinical benefit to participants at the selected recommended phase 2 (RP2D) dose in Part A.
Enrollment: 31.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-04-23
Primary completion date: 2020-02-27
Completion date: 2020-02-27
Baseline population: The safety population was defined as all participants who received at least 1 dose of study drug.
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 NCT04102007: A Study of the Safety and Efficacy of Risankizumab in Adult Participants With Plaque Psoriasis Who Have Had a Suboptimal Response to Secukinumab or Ixekizumab
Official title: A Phase 3b, Multicenter, Interventional, Open-label Study of Adult Subjects With Moderate to Severe Plaque Psoriasis Who Have a Suboptimal Response to Secukinumab or Ixekizumab and Are Switched to Risankizumab
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 244.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-12
Primary completion date: 2022-01-17
Completion date: 2022-11-07
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT03875859: Topical Remetinostat Gel as Neoadjuvant Therapy in Patients With Squamous Cell Carcinoma (SCC)
Official title: A Phase 2 Open Label, Single Arm Trial to Investigate the Efficacy and Safety of Topical Remetinostat Gel as Neoadjuvant Therapy in Patients Undergoing Surgical Resection of Squamous Cell Carcinoma (SCC)
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The available study medication reached expiry (logistics).
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-12-12
Primary completion date: 2020-05-14
Completion date: 2021-01-30
Plan to share individual participant data: NO
Clinical trial NCT03596970: Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients.
Official title: A 24-month Multi-center, Open-label, Randomized, Controlled Study to Evaluate the Evolution of Renal Function in Maintenance Liver Transplant Recipients Receiving Either RAD001 (Everolimus) Plus Reduced TAC or RAD001 (Everolimus) Plus Mycophenolate Mofetil (MMF)
Acronym: Prometheus
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-09-30
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Clinical trial NCT00567567: Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma
Official title: Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma
Sponsor: Children's Oncology Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 665.0 (ACTUAL)
Number of arms: 2.0
Start date: 2007-11-05
Primary completion date: 2015-02-27
Completion date: 2022-03-31
Clinical trial NCT00442130: Reduced Intensity Stem Cell Transplantation for Chronic Lymphocytic Leukemia Followed by Vaccination
Official title: Reduced Intensity Stem Cell Transplantation for Advanced Chronic Lymphocytic Leukemia Followed by Vaccination With Lethally Irradiated Autologous Tumor Cells Admixed With Granulocyte Macrophage-colony Stimulating Factor Secreting K562 Cells
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 27.0 (ACTUAL)
Number of arms: 1.0
Start date: 2007-02-28
Primary completion date: 2014-02-28
Completion date: 2020-04-30
Clinical trial NCT04066595: Cabozantinib in Patients With Locally Advanced or Metastatic Urothelial Cell Carcinoma.
Official title: Cabozantinib in Patients With Locally Advanced or Metastatic Urothelial Cell Carcinoma Who Have Progressed After Cisplatin-based Chemotherapy and Anti-PD-1/PD-L1 Therapy or After Anti-PD-1/PD-L1 Therapy Only.
Acronym: CabUC
Sponsor: Johannes Gutenberg University Mainz (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Recruitment problems
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-02-10
Primary completion date: 2021-07-01
Completion date: 2021-07-01
Clinical trial NCT02233829: Dopamine Rhythms in Health and Addiction
Official title: Dopamine Rhythms in Health and Addiction
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: No enrollment, delay with drug availability.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2024-04-23
Primary completion date: 2024-04-23
Completion date: 2024-04-23
Plan to share individual participant data: NO
IPD sharing description: .Data is analyzed by subject group and not on an individual basis.
Clinical trial NCT03806985: Effects of Psilocybin in Concussion Headache
Official title: Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study II
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Challenging to recruit qualifying subjects
Enrollment: 12.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-03-28
Primary completion date: 2023-06-27
Completion date: 2023-06-27
Clinical trial NCT02393248: Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101)
Official title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (FIGHT-101)
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Enrollment: 201.0 (ACTUAL)
Number of arms: 25.0
Start date: 2015-02-27
Primary completion date: 2021-12-17
Completion date: 2021-12-17
Clinical trial NCT03149549: PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors
Official title: A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009)
Sponsor: CytomX Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Covid Pandemic; Business Decision to separate Phase 2 to new study
Enrollment: 99.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-06-01
Primary completion date: 2020-09-10
Completion date: 2020-09-10
Baseline population: Summaries are presented by dose and schedule. Specifically, all available data from Parts A, A2, and B is pooled by dose group; Part C1 dosing 4 mg/kg Q2W and 6 mg/kg Q2W are also presented by dose and schedule.
Limitations and caveats: This study was terminated early due to the Covid Pandemic and the company's business decision to separate the Phase 2 (part B) course of the study to a separate, new Phase 2 study. The Phase 1 (part A) course of the study was completed and the RP2D was determined. Part B only enrolled 3 patients and the Secondary and other Outcomes were not analyzed.
Plan to share individual participant data: NO