chufangao/CTO huggingface dataset:
Clinical trial NCT04744103: Trichloroacetic Acid as a Topical Treatment for Actinic Cheilitis
Official title: Trichloroacetic Acid as a Topical Treatment for Actinic Cheilitis
Sponsor: Nova Scotia Health Authority (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: This study has been on hold due to the COVID-19 pandemic. Recruitment never began and the team didn't renew the study
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-09-15
Primary completion date: 2023-09-15
Completion date: 2023-09-15
Plan to share individual participant data: NO
IPD sharing description: Participant data will not be used outside the confines of this study.
Clinical trial NCT03890341: Study in Women on the Effect of JNJ-64530440 on Oral Contraceptive and Midazolam, and the Effect of a High-fat Meal on JNJ-64530440
Official title: A Study in Healthy Female Participants to Investigate the Effect of JNJ-64530440 on the Single-dose of Ethinylestradiol and Drospirenone (Oral Contraceptive), and Midazolam, and the Effect of a High-fat Meal on the Single-dose of JNJ-64530440
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Stopped due to a strategic decision.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-06-01
Primary completion date: 2021-08-01
Completion date: 2021-11-01
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT04938427: A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS)
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 270.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-08
Primary completion date: 2024-01-25
Completion date: 2024-01-25
Baseline population: Safety Analysis Set included all participants who took 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 NCT03399838: Comparing in Dexmedetomidine With po/pr Midazolam for Procedural Sedation in the Pediatric Emergency Department
Official title: The PedINDex Study: Comparing Intranasal Dexmedetomidine With Oral or Rectal Midazolam for Procedural Sedation in the Pediatric Emergency Department.
Acronym: PedINDEX
Sponsor: Insel Gruppe AG, University Hospital Bern (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Sponsor left the hospital
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-08-31
Primary completion date: 2024-07-31
Completion date: 2024-08-31
Plan to share individual participant data: NO
Clinical trial NCT05028946: A Study of Oral Foralumab in Participants With Moderate to Severely Active Crohn's Disease
Official title: A Phase IB Multiple Ascending Dose Study of Safety and Tolerability of Orally Administered Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, in Subjects With Moderate to Severely Active Crohn's Disease
Sponsor: Tiziana Life Sciences LTD (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: For business reasons
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-05-01
Primary completion date: 2023-07-07
Completion date: 2023-11-07
Plan to share individual participant data: NO
Clinical trial NCT05077423: A Phase 1 Trial of CD33xCD3 BsAb in Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia
Official title: A Phase 1, Open-label, Dose-escalation Trial of CD33xCD3 Bispecific Antibody in Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia
Sponsor: Y-mAbs Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study terminated due to business priorities
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-05-25
Primary completion date: 2022-12-01
Completion date: 2022-12-01
Plan to share individual participant data: NO
Clinical trial NCT02555657: Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119)
Official title: A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab Versus Single Agent Chemotherapy Per Physician's Choice for Metastatic Triple Negative Breast Cancer (mTNBC) - (KEYNOTE-119)
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 622.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-10-13
Primary completion date: 2019-04-11
Completion date: 2020-11-10
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT03746002: Diuretic Effect of Metolazone Pre-dosing Versus Concurrent Dosing
Official title: Diuretic Effect of Metolazone Pre-dosing Versus Concurrent Dosing With Furosemide: a Pilot Study
Sponsor: University of Maryland, Baltimore (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Insufficient rate of patient enrollment/accrual.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-01
Primary completion date: 2020-01-10
Completion date: 2020-01-10
Limitations and caveats: This study was terminated early due to slow enrollment, resulting in an inadequate sample size.
Plan to share individual participant data: NO
Clinical trial NCT03110562: Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma
Official title: A Phase 3 Randomized, Controlled, Open-label Study of Selinexor, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
Acronym: BOSTON
Sponsor: Karyopharm Therapeutics Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 402.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-05-24
Primary completion date: 2020-02-18
Completion date: 2022-05-12
Baseline population: Intent-to-treat (ITT) population consisted of all participants who were randomized to the study treatment, regardless of whether or not they received the study treatment.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04001998: Healthy Volunteer Study Comparing Tablet and Capsule Formulations
Official title: A Two-Part, Open Label, Complete Crossover Study to Compare the Tablet and Capsule Formulations of BLD-2660, Including a Food Effect Assessment of the Tablet Formulation, and to Assess Dose Proportionality Following Single Oral Doses of BLD-2660 in Tablet Formulation
Sponsor: Blade Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: On hold to determine chosen formulations
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-28
Primary completion date: 2021-06-30
Completion date: 2021-07-31
Plan to share individual participant data: NO
Clinical trial NCT04885634: Semaglutide for the Reduction of Arrhythmia Burden in Overweight AF Patients
Official title: Semaglutide for the Reduction of Arrhythmia Burden in Overweight and Obese Patients With Atrial Fibrillation (Pilot Study)
Acronym: SOCRATES-AF
Sponsor: Odense University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Not received funding.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-10-31
Primary completion date: 2024-01-31
Completion date: 2024-11-30
Plan to share individual participant data: NO
Clinical trial NCT04491084: FLT3 Ligand, CD40 Agonist Antibody, and Stereotactic Radiotherapy
Official title: FLT3 Ligand (CDX-301), CD40 Agonist Antibody (CDX-1140), and Stereotactic Radiotherapy Versus Standard Therapy for Advanced Non-small Cell Lung Cancer: A Phase I/II Randomized Trial
Acronym: FLT3
Sponsor: Albert Einstein College of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Low accrual
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-01
Primary completion date: 2022-08-18
Completion date: 2022-08-18
Clinical trial NCT04380142: Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease
Official title: A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 174.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-19
Primary completion date: 2021-09-29
Completion date: 2021-09-29
Baseline population: Safety Analysis Set: All participants who received any dose of study drug during the Double-Blind Treatment Period.
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: For details on when studies are available for sharing, please refer to the link below.
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 Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT03866980: A Study of Anti-PD-1 AK105 in Patients With Metastatic Nonsquamous Non-small Cell Lung Cancer
Official title: A Phase III, Randomized, Double-blinded, Multicenter Study of AK105 Combined With Carboplatin and Pemetrexed vs Placebo Combined With Carboplatin and Pemetrexed as First-line Therapy in Patients With Metastatic Nonsquamous Non-small Cell Lung Cancer
Sponsor: Akeso (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: corporate strategy adjustment
Enrollment: 164.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-11-27
Primary completion date: 2023-06-30
Completion date: 2023-12-31
Plan to share individual participant data: NO
Clinical trial NCT03641547: M6620 Plus Standard Treatment in Oesophageal and Other Cancer
Official title: A Phase 1 Dose Escalation Safety Study Combining the ATR Inhibitor M6620 With Chemoradiotherapy in Oesophageal Cancer & Other Solid Cancers Using Time to Event Continual Reassessment Method
Acronym: CHARIOT
Sponsor: University of Oxford (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-12-04
Primary completion date: 2022-04-04
Completion date: 2022-04-04
Clinical trial NCT04509999: Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection
Official title: Randomized Trial of Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection
Sponsor: University of Florida (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: No patients enrolled and funding withdrawn
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-26
Primary completion date: 2021-06-30
Completion date: 2021-06-30
Plan to share individual participant data: NO
Clinical trial NCT04150341: Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response
Official title: A Randomized, Double-blind, Placebo-controlled, 3-period Crossover Study to Evaluate the Effects of Repeated Doses of Inhaled TD-8236 and Impact on Airway Responses Following Allergen Challenge in Patients With Asthma
Sponsor: Theravance Biopharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 24.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-11-06
Primary completion date: 2020-08-28
Completion date: 2020-09-03
Plan to share individual participant data: NO
IPD sharing description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Clinical trial NCT04354259: Interferon Lambda for Immediate Antiviral Therapy at Diagnosis in COVID-19
Official title: Interferon Lambda for Immediate Antiviral Therapy at Diagnosis (ILIAD): A Phase II Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Effect of Peginterferon Lambda for the Treatment of COVID-19
Acronym: ILIAD
Sponsor: University Health Network, Toronto (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 157.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-05-13
Primary completion date: 2022-08-19
Completion date: 2022-12-08
Plan to share individual participant data: NO
Clinical trial NCT04684914: HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB)
Official title: Phase 2, Double-blind, Randomized, Placebo-controlled Study of HepTcell (Adjuvanted FP-02.2) as an Immunotherapeutic Vaccine in Treatment-naïve Patients With Inactive Chronic Hepatitis B (CHB)
Sponsor: Altimmune, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Did not meet endpoints
Enrollment: 87.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-26
Primary completion date: 2024-03-27
Completion date: 2024-04-17
Plan to share individual participant data: NO
Clinical trial NCT04691375: A Study of PY314 in Subjects With Advanced Solid Tumors
Official title: A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY314 as a Single Agent and In Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Sponsor: Ikena Oncology (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor business decision.
Enrollment: 86.0 (ACTUAL)
Number of arms: 14.0
Start date: 2020-10-29
Primary completion date: 2023-08-31
Completion date: 2023-09-22
Plan to share individual participant data: NO
Clinical trial NCT04656418: CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy and Safety of Subcutaneous Administration of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema
Sponsor: CSL Behring (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 64.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-27
Primary completion date: 2022-06-07
Completion date: 2022-06-07
Baseline population: ITT analysis set included all the randomized participants who provided written informed consent and underwent study screening procedures.
Plan to share individual participant data: YES
IPD sharing description: CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.~Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.~If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
IPD time frame: IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
IPD access criteria: Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.~An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.~The requesting party must execute an appropriate data sharing agreement before IPD will be made available.
Clinical trial NCT04880850: A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Glargine, Both in Combination With Mealtime Insulin, in People With Type 2 Diabetes Who Use Daily Insulin and Mealtime Insulin (ONWARDS 4)
Official title: A 26-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Bolus Insulin With or Without Non-insulin Anti-diabetic Drugs, in Subjects With Type 2 Diabetes on a Basal-bolus Regimen
Acronym: ONWARDS 4
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 582.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-14
Primary completion date: 2022-06-16
Completion date: 2022-06-16
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT05511519: Study of ATI-450 vs Placebo in Patients With Moderate to Severe Psoriatic Arthritis
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zunsemetinib vs Placebo in Patients With Moderate-to-Severe Active Psoriatic Arthritis
Sponsor: Aclaris Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 47.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-07-12
Primary completion date: 2023-12-06
Completion date: 2024-01-03
Clinical trial NCT05131477: Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study
Official title: A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Dose Ranging Study of a Subcutaneous Anti-OX40L Monoclonal Antibody (KY1005) in Moderate-to-Severe Atopic Dermatitis
Acronym: STREAM-AD
Sponsor: Kymab Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 390.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-12-13
Primary completion date: 2023-04-26
Completion date: 2024-02-21
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 clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.~Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT04756206: Role of Dutasteride in Treatment of Chronic Prostatitis
Official title: Role of Dutasteride in Treatment of Category IIIB Chronic Prostatitis (A Placebo-Controlled Study)
Sponsor: Ain Shams University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-01
Primary completion date: 2020-01-01
Completion date: 2020-09-01
Plan to share individual participant data: NO
Clinical trial NCT04528758: F-18 Rhodamine 6G PET Imaging for Myocardial Blood Flow
Official title: Preliminary Evaluation of F-18 Rhodamine 6G in Healthy Individuals and Patients With Stable Heart Condition
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: SUSPENDED 
Why stopped: re-evaluation of radiotracer
Enrollment: 15.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2018-10-16
Primary completion date: 2024-06-30
Completion date: 2024-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05317013: CBD in Postmenopausal Women With Osteopenia
Official title: A Randomized, Double-Blind, Placebo-Controlled, Repeated-Dose Study to Assess the Safety, Tolerability, and Preliminary Effects of CHI-554 in Postmenopausal Women With Osteopenia
Sponsor: Canopy Growth Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Low enrollment
Enrollment: 2.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-05-01
Primary completion date: 2022-09-22
Completion date: 2022-09-22
Clinical trial NCT02487082: Pilot Study of Sleep Therapy and Biomarkers in Children With Autism Spectrum Disorders
Official title: Pilot Study of Sleep Therapy and Biomarkers in Children With Autism Spectrum Disorders
Sponsor: Stony Brook University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: too few subjects enrolled
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-06-30
Primary completion date: 2020-12-31
Completion date: 2021-01-29
Limitations and caveats: No statistical comparisons were undertaken due to the small sample size in the two groups. Study enrollment/completion proved insufficient to permit any conclusions to be drawn. Enrollment/completion was likely limited because of the study requirement that all prior sleep medications, including melatonin, be discontinued as a condition for study participation.
Plan to share individual participant data: NO
Clinical trial NCT02592707: Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPS201 in NETs
Official title: An International, Multicenter, Open-label Study to Evaluate Safety, Tolerability, Biodistribution, Dosimetry and Preliminary Efficacy of 177Lu-OPS201 for the Therapy of Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)
Sponsor: Ipsen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Terminated (Due to small number of ongoing patients. Patients ongoing at time of termination could choose to join study D-FR-01072-004 for long term follow-up.
Enrollment: 40.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-03-06
Primary completion date: 2022-02-22
Completion date: 2022-02-22
Baseline population: The safety analysis set (SAS) included all participants who received 177Lu-IPN01072.
Limitations and caveats: Due to strategic reasons, the Ipsen management team decided to early terminate the D-FR-01072-001 / OPS-C-001 study. This decision was not due to any safety or tolerability concern, or any event associated with the use of the study drug.