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NCT01140347 · ClinicalTrials.gov registry record · Phase 3
A Study of Ramucirumab (IMC-1121B) Drug Product (DP) and Best Supportive Care (BSC) Versus Placebo and BSC as 2nd-Line Treatment in Participants With Hepatocellular Carcinoma After 1st-Line Therapy With Sorafenib
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 565
- Enrollment target
NCT01140347: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01140347 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 565 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01140347, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 565 participants
- Enrollment target
Study Summary
This is a Phase 3 multicenter, randomized study evaluating the safety and efficacy of ramucirumab DP plus BSC as a double-blind, placebo-controlled (placebo plus BSC) comparison. Approximately 544 participants, at least 18 years of age, with Child-Pugh score \< 7 and diagnosed with hepatocellular carcinoma will be randomized. Participants must have received sorafenib as first-line systemic treatment for hepatocellular carcinoma (HCC), and must have discontinued sorafenib prior to entering the study. Hypothesis: This sample size will allow differentiation of the expected increase in median overall survival (OS), from 8 months in the placebo arm to 10.67 months in the ramucirumab arm. Upon registration and completion of screening procedures, eligible participants with HCC who have disease progression during or following first-line therapy with sorafenib, or were intolerant to this agent, will be randomized to receive either ramucirumab DP or placebo. The treatment regimen will be continued until radiographic or symptomatic progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the participant, or investigator decision.
Primary Outcome
OS was defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up were censored on the last date the participant was known to be alive.
Interventions
- BIOLOGICAL Placebo
- OTHER BSC
- BIOLOGICAL Ramucirumab DP (IMC-1121B)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 565 participants |
| Start Date | 2010-10 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
What the finished NCT01140347 record still lists
NCT01140347 is an interventional study that assigns participants to a tested intervention. The registered 565 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01140347 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01140347 about?
NCT01140347 is a clinical study titled "A Study of Ramucirumab (IMC-1121B) Drug Product (DP) and Best Supportive Care (BSC) Versus Placebo and BSC as 2nd-Line Treatment in Participants With Hepatocellular Carcinoma After 1st-Line Therapy With Sorafenib". This is a Phase 3 multicenter, randomized study evaluating the safety and efficacy of ramucirumab DP plus BSC as a double-blind, placebo-controlled (placebo plus BSC) comparison. Approximately 544 participants, at least 18 years of age, with Child-Pugh score \< 7 and diagnosed with hepatocellular c...
What is the current status of trial NCT01140347?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 565 participants. The study started on 2010-10. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01140347?
The interventions under investigation include: Placebo (BIOLOGICAL), BSC (OTHER), Ramucirumab DP (IMC-1121B) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01140347?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01140347's enrollment target sits among peer trials
565 667th of 2000 higher than 1,333 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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