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NCT01519414 · ClinicalTrials.gov registry record · Phase 2
Tivantinib in Treating Patients With Metastatic Prostate Cancer
A Phase 2 study of Prostate Adenocarcinoma and Recurrent Prostate Carcinoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 20
- Study locations
NCT01519414: Completed Phase 2 study of Prostate Adenocarcinoma and Recurrent Prostate Carcinoma, sponsored by National Cancer Institute (NCI).
NCT01519414 is a Phase 2 study of Prostate Adenocarcinoma and Recurrent Prostate Carcinoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 78 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01519414, a Phase 2 study of Prostate Adenocarcinoma and Recurrent Prostate Carcinoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase II trial studies how well tivantinib works compared to placebo in treating patients with metastatic prostate cancer. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
The progression-free survival distributions between the two arms will be compared using log-rank tests. Progression-free survival curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model.
Conditions Studied
Interventions
- OTHER Placebo
- OTHER Laboratory Biomarker Analysis
- DRUG Tivantinib
Study Locations (20)
Illinois
- Northwestern University - Chicago
- Michael Reese Hospital - Chicago
- University of Chicago Comprehensive Cancer Center - Chicago
- Decatur Memorial Hospital - Decatur
- NorthShore University HealthSystem-Evanston Hospital - Evanston
- Ingalls Memorial Hospital - Harvey
- Illinois CancerCare-Peoria - Peoria
- Southern Illinois University School of Medicine - Springfield
Ohio
- Case Western Reserve University - Cleveland
- Cleveland Clinic Foundation - Cleveland
- Ohio State University Comprehensive Cancer Center - Columbus
Indiana
- Fort Wayne Medical Oncology and Hematology Inc - Jefferson Boulevard - Fort Wayne
- Indiana University/Melvin and Bren Simon Cancer Center - Indianapolis
Maryland
- University of Maryland/Greenebaum Cancer Center - Baltimore
- University of Maryland Saint Joseph Medical Center - Towson
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Florida
- Moffitt Cancer Center - Tampa
Missouri
- Mercy Hospital Saint Louis - St Louis
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2012-01-11 |
| Est. Completion | 2015-08-18 |
| Phase | Phase 2 |
What the finished NCT01519414 record still lists
NCT01519414 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (64% lower).
The record links to 4 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01519414 names 20 study sites across 9 states, led by Illinois, Ohio, Indiana.
Frequently Asked Questions
What is clinical trial NCT01519414 about?
NCT01519414 is a clinical study titled "Tivantinib in Treating Patients With Metastatic Prostate Cancer". This randomized phase II trial studies how well tivantinib works compared to placebo in treating patients with metastatic prostate cancer. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
What is the current status of trial NCT01519414?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2012-01-11. Estimated completion is 2015-08-18.
What conditions does trial NCT01519414 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer, Hormone-Resistant Prostate Cancer.
What interventions are being tested in trial NCT01519414?
The interventions under investigation include: Placebo (OTHER), Laboratory Biomarker Analysis (OTHER), Tivantinib (DRUG).
Who is sponsoring clinical trial NCT01519414?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01519414 being conducted?
This trial has 20 study locations across District of Columbia, Florida, Illinois, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Adenocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01519414's enrollment target sits among peer trials
78 50th of 99 higher than 50 of 99 other Prostate Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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