chufangao/CTO huggingface dataset:
Clinical trial NCT04655508: Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 ≥10% From Pre Transplantation
Official title: Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 ≥10% From Pre Transplantation
Acronym: RESPPEDOBS
Sponsor: Assistance Publique - Hôpitaux de Paris (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: insufficient enrollment.
Enrollment: 35.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-21
Primary completion date: 2023-09-27
Completion date: 2023-09-27
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03857542: A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
Official title: A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of AGN-190584 in Participants With Presbyopia
Acronym: GEMINI 2
Sponsor: Allergan (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 427.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-01
Primary completion date: 2020-09-10
Completion date: 2020-09-10
Baseline population: Intent-to-treat (ITT) population included all randomized participants.
Limitations and caveats: DCNVA measurements at 1 site were not conducted correctly at the screening and baseline visits; all participants from this site were excluded from efficacy analyses.
Plan to share individual participant data: YES
IPD sharing description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
IPD time frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
IPD access criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
Clinical trial NCT03355066: A Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors
Official title: A Phase 1, Open-Label, Dose-Escalation, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors
Sponsor: Biosplice Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study was terminated due business reasons by Sponsor.
Enrollment: 82.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-11-06
Primary completion date: 2022-11-14
Completion date: 2022-11-14
Plan to share individual participant data: NO
Clinical trial NCT04747275: Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients
Official title: Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients
Sponsor: Children's Mercy Hospital Kansas City (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Transitioned to multi site study with sponsor
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-18
Primary completion date: 2021-11-01
Completion date: 2021-11-01
Baseline population: 6 subjects were enrolled and completed the study, however, due to concerns with data collection and integrity, we elected to not use those subjects data moving forward. No further subjects were recruited prior to the study closing
Plan to share individual participant data: NO
Clinical trial NCT02531295: Immunologic Response to Kansui in Treated HIV+ Individuals: a Dose Escalation Study
Official title: Immunologic Response to Euphorbia Kansui Extract Powder Prepared as Tea in HIV-infected Antiretroviral Therapy (ART)-Suppressed Individuals: a Dose Escalation Study
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Pause on clinical trial enrollment due to grant funding cuts after COVID-19
Enrollment: 5.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-05-15
Primary completion date: 2020-03-19
Completion date: 2020-03-19
Baseline population: The study was terminated (Halted Prematurely).
Clinical trial NCT04331795: Tocilizumab to Prevent Clinical Decompensation in Hospitalized, Non-critically Ill Patients With COVID-19 Pneumonitis
Official title: Early Institution of Tocilizumab Titration in Non-Critical Hospitalized COVID-19 Pneumonitis
Acronym: COVIDOSE
Sponsor: University of Chicago (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-04
Primary completion date: 2020-06-05
Completion date: 2020-06-05
Plan to share individual participant data: NO
Clinical trial NCT05543928: Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism
Official title: A Multi-Center Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CTAP101 Extended-release Capsules to Treat Secondary Hyperparathyroidism in Pediatric Subjects of Ages 8 to <18 Years With Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency
Sponsor: OPKO Health, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: FDA changed the post-marketing requirement necessitating a new study design and protocol.
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-01-31
Primary completion date: 2024-06-19
Completion date: 2024-06-19
Plan to share individual participant data: NO
Clinical trial NCT04737174: ES-481 for Uncontrolled Glioma-Associated Epilepsy and Assessment for Potential Anti-Tumorigenic Effect in Patients With Isocitrate Dehydrogenase 1 (IDH1) Mutant Tumors
Official title: Adjunctive ES-481 for Uncontrolled Glioma-Associated Epilepsy and Assessment for Potential Anti-Tumorigenic Effect in Patients With Isocitrate Dehydrogenase 1 (IDH1) Mutant Tumors
Sponsor: ES Therapeutics Australia Pty Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Lack of identifiable patients
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-03-25
Primary completion date: 2021-10-31
Completion date: 2022-04-30
Clinical trial NCT04109690: CPX-351 in Patients Treated for Higher-risk Myelodysplastic Syndromes Experiencing Hypomethylating Agent Failure.
Official title: A Phase I-II Study of a Liposomal Formulation of Cytarabine and Daunorubicin (CPX-351) in Patients Treated for Higher-risk Myelodysplastic Syndromes Experiencing Hypomethylating Agent Failure.
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Failure to enroll
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-12-30
Primary completion date: 2021-07-27
Completion date: 2021-07-27
Clinical trial NCT03625505: A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia
Official title: A Multicenter, Open-Label Phase 1b Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 61.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-18
Primary completion date: 2021-08-31
Completion date: 2021-08-31
Plan to share individual participant data: NO
Clinical trial NCT04006145: A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH
Official title: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Explore the Efficacy and Safety of Elobixibat in Adults With Nonalcoholic Fatty Liver Disease (NAFLD) or Nonalcoholic Steatohepatitis (NASH)
Sponsor: AlbireoPharma (UNKNOWN)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 47.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-06
Primary completion date: 2020-06-26
Completion date: 2020-07-15
Clinical trial NCT04385433: A Comparative Study of Pravastatin vs Placebo as Primary Prevention of Severe Subcutaneous Breast Fibrosis in Hyper-radiosensitive Identified Patients With Breast Cancer
Official title: A Comparative Study of Pravastatin vs Placebo as Primary Prevention of Severe Subcutaneous Breast Fibrosis in Hyper-radiosensitive Identified Patients With Breast Cancer
Acronym: PRAVAPREV-01
Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Not enough patients enrolled
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-04
Primary completion date: 2023-04-27
Completion date: 2023-04-27
Clinical trial NCT04464967: Safety and Preliminary Efficacy of SNK01 in Combination With Trastuzumab or Cetuximab in Subjects With Advanced HER2 or EGFR Cancers
Official title: A Phase 1/2a, Open-Label, Multi-Center Study Evaluating the Safety and Anti-Tumor Activity of Ex Vivo Expanded, Autologous Natural Killer Cells (SNK01) in Combination With Trastuzumab or Cetuximab in Subjects With Advanced/Metastatic HER2- or EGFR-Expressing Cancers
Sponsor: NKGen Biotech, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Trial not initiated
Enrollment: 0.0 (ACTUAL)
Number of arms: 6.0
Start date: 2021-03-31
Primary completion date: 2022-08-31
Completion date: 2023-02-28
Clinical trial NCT04330144: Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)
Official title: A Study of Hydroxychloroquine as Post Exposure Prophylaxis for SARS-CoV-2(HOPE Trial)
Acronym: COVID-19
Sponsor: Gangnam Severance Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: No Participants Enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-01
Primary completion date: 2020-06-29
Completion date: 2020-06-29
Clinical trial NCT02367781: A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Official title: A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Nab-Paclitaxel for Chemotherapy-Naive Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Acronym: IMpower130
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 723.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-04-16
Primary completion date: 2018-03-15
Completion date: 2021-01-18
Clinical trial NCT03976206: Very Small Embryonic-like Stem Cells for Facial Skin Antiaging
Official title: Autologous Very Small Embryonic-like Stem Cells(VSELs) for Facial Skin Antiaging
Sponsor: Fuda Cancer Hospital, Guangzhou (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Policy changes have contributed to the failure to carry out smoothly
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-07-06
Primary completion date: 2020-05-20
Completion date: 2020-07-01
Plan to share individual participant data: NO
Clinical trial NCT03628924: A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
Official title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Subjects With Moderate to Severe Hidradenitis Suppurativa
Acronym: NOVA
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 184.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-09-04
Primary completion date: 2020-05-22
Completion date: 2020-05-22
Clinical trial NCT04342221: Hydroxychloroquine for COVID-19
Official title: Randomized Controlled Trial of Hydroxychloroquine Versus Placebo for the Treatment of Adult Patients With Acute Coronavirus Disease 2019 - COVID-19
Acronym: COV-HCQ
Sponsor: University Hospital Tuebingen (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Reduced acceptance of IMP
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-29
Primary completion date: 2021-02-26
Completion date: 2021-02-26
Clinical trial NCT03526185: A Pilot Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes
Official title: A Pilot Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Melanoma
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: lack of funds
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-02-06
Primary completion date: 2020-12-01
Completion date: 2020-12-01
Clinical trial NCT03445000: ALEctinib for the Treatment of Pretreated RET-rearranged Advanced Non-small Cell Lung Cancer
Official title: A Single Arm Phase II Trial Evaluating the Activity of Alectinib for the Treatment of Pretreated RET-rearranged Advanced NSCLC
Acronym: ALERT-lung
Sponsor: ETOP IBCSG Partners Foundation (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low recruitment rate
Enrollment: 14.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-11-06
Primary completion date: 2021-03-31
Completion date: 2021-03-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04530474: Outpatient Use of Ivermectin in COVID-19
Official title: Outpatient Use of Ivermectin in COVID-19
Sponsor: Temple University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: WHO report
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-01
Primary completion date: 2021-06-30
Completion date: 2021-06-30
Plan to share individual participant data: NO
Clinical trial NCT03987503: The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study
Official title: The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study
Acronym: NOW
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 86.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-01
Primary completion date: 2022-10-30
Completion date: 2022-12-29
Plan to share individual participant data: NO
IPD sharing description: Summary statistics of primary and secondary outcome data and overall sample demographics (e.g., gender, age, ethnicity/race) will be shared with researchers through annual conference presentations and final results related to the study aims will be disseminated via peer-reviewed manuscripts.
Clinical trial NCT03669549: Nevanimibe HCl for the Treatment of Classic CAH
Official title: A Multicenter Dose-Titration Open-Label Study of Nevanimibe Hydrochloride for the Treatment of Classic Congenital Adrenal Hyperplasia
Sponsor: Millendo Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Following an interim data review, further investment in nevanimibe has been discontinued
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-07-11
Primary completion date: 2020-06-03
Completion date: 2020-07-12
Limitations and caveats: Nevanimibe hydrochloride administered orally at doses of 500-2000 mg BID for up to 16 weeks in the first 10 evaluable patients did not result in sufficient efficacy. The Sponsor has decided to refrain from further development at this time.
Plan to share individual participant data: NO
Clinical trial NCT04750759: Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat
Official title: A Randomized, Single Blind, Placebo-controlled, Multiple Dose, Parallel-arm Study to Investigate the Safety and Preliminary Efficacy of the Combination of Niclosamide and Camostat to Treat COVID-19 (NICCAM)
Acronym: NICCAM
Sponsor: Charité Research Organisation GmbH (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: sub-therapeutic plasma levels of active substance
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-03
Primary completion date: 2021-10-29
Completion date: 2021-10-29
Plan to share individual participant data: NO
Clinical trial NCT02426125: A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ramucirumab Plus Docetaxel Versus Placebo Plus Docetaxel in Patients With Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or After Platinum-Based Therapy
Acronym: RANGE
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 530.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-07-13
Primary completion date: 2017-04-21
Completion date: 2022-07-26
Baseline population: All randomized participants.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and 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 NCT05255484: Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumours
Official title: A Phase I/II, Open-Label, Dose Escalation and Expansion Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Advanced Solid Tumors
Sponsor: LaNova Medicines Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Completed primary objective.
Enrollment: 24.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-05-26
Primary completion date: 2023-10-06
Completion date: 2023-10-06
Plan to share individual participant data: NO
Clinical trial NCT04157088: Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC)
Official title: A Randomized, Open-label, Multicenter, Phase 2b Study to Evaluate Physical Function, Including Balance and Daily Activity, in Participants With Castration-resistant Prostate Cancer Treated With Darolutamide or Enzalutamide
Acronym: DaroAcT
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The results of the lead-in phase did not fulfill the criteria set for moving into the randomized phase
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-17
Primary completion date: 2022-07-08
Completion date: 2022-07-08
Limitations and caveats: A total of 30 participants received treatment with darolutamide 600 mg twice daily in the lead in phase of the study, comprising the safety evaluable population.~No participant received either darolutamide or enzalutamide in the randomized phase of the study as the study was terminated prematurely prior to the initiation of the randomized phase of the study.
Plan to share individual participant data: NO
IPD sharing description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Clinical trial NCT03836157: Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer
Official title: Phase II Trial of Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer
Sponsor: University of Oklahoma (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study was not initiated.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-05-31
Primary completion date: 2021-11-30
Completion date: 2022-05-31
Plan to share individual participant data: NO
Clinical trial NCT04003974: Efficacy and Safety of Losmapimod in Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD)
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 48-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD)
Acronym: FSHD
Sponsor: Fulcrum Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-09
Primary completion date: 2021-01-28
Completion date: 2021-01-28
Baseline population: Full Analysis Set: included all participants who were randomly assigned to receive double-blind study drug in the placebo-controlled treatment period.
Plan to share individual participant data: NO
Clinical trial NCT03138538: M8891 First in Human in Solid Tumors
Official title: An Open-label, Phase I Dose Escalation Trial of Methionine Aminopeptidase 2 Inhibitor M8891 in Subjects With Advanced Solid Tumors
Acronym: M8891
Sponsor: EMD Serono (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: As part of a portfolio-level management of the company's oncology pipeline, it was decided to stop the next phase of internal development of the MetAP2 (M8891) program to enable realization of other opportunities within the oncology portfolio.
Enrollment: 27.0 (ACTUAL)
Number of arms: 6.0
Start date: 2017-08-08
Primary completion date: 2020-09-16
Completion date: 2020-09-16
Baseline population: Safety analysis set included all participants who received at least 1 dose of study drug.
Plan to share individual participant data: NO
IPD sharing description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html