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NCT01755767 · ClinicalTrials.gov registry record · Phase 3
Study of Tivantinib in Subjects With Inoperable Hepatocellular Carcinoma (HCC) Who Have Been Treated With One Prior Therapy
A Phase 3 study of Hepatocellular Carcinoma, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 3
- Development phase
- 383
- Enrollment target
- 20
- Study locations
NCT01755767: Completed Phase 3 study of Hepatocellular Carcinoma, sponsored by Daiichi Sankyo.
NCT01755767 is a Phase 3 study of Hepatocellular Carcinoma that has completed, run by Daiichi Sankyo. The registered enrollment target is 383 participants, above the 255-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (50% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01755767, a Phase 3 study of Hepatocellular Carcinoma, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 383 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine if tivantinib (ARQ 197) is effective in treating patients with MET diagnostic-high hepatocellular carcinoma (liver cancer) who have already been treated once with another therapy.
Primary Outcome
Overall survival (OS) is defined as the time from randomization to the date of death. The rate of OS (percentage of participants still alive) was determined only in the tivantinib 120 mg BID cohort.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tivantinib
Study Locations (20)
Texas
- - Dallas
- - Galveston
- - Houston
California
- - Los Angeles
- - Orange
Arizona
- - Tucson
District of Columbia
- - Washington D.C.
Florida
- - Gainesville
Illinois
- - Chicago
Kansas
- - Westwood
Louisiana
- - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 383 participants |
| Start Date | 2012-12-27 |
| Est. Completion | 2017-07-31 |
| Phase | Phase 3 |
What the finished NCT01755767 record still lists
NCT01755767 is an interventional study that assigns participants to a tested intervention. The registered 383 participants enrollment target is mid-sized for trials with a published cap, above the 255-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (50% higher).
The record links to 1 condition, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01755767 names 20 study sites across 17 states, led by Texas, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT01755767 about?
NCT01755767 is a clinical study titled "Study of Tivantinib in Subjects With Inoperable Hepatocellular Carcinoma (HCC) Who Have Been Treated With One Prior Therapy". The purpose of this study is to determine if tivantinib (ARQ 197) is effective in treating patients with MET diagnostic-high hepatocellular carcinoma (liver cancer) who have already been treated once with another therapy.
What is the current status of trial NCT01755767?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 383 participants. The study started on 2012-12-27. Estimated completion is 2017-07-31.
What conditions does trial NCT01755767 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma.
What interventions are being tested in trial NCT01755767?
The interventions under investigation include: Placebo (DRUG), Tivantinib (DRUG).
Who is sponsoring clinical trial NCT01755767?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01755767 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatocellular Carcinoma
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 NCT01755767's enrollment target sits among peer trials
383 33rd of 145 higher than 113 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma 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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