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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 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 565 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01140347
The ClinicalTrials.gov registry entry for NCT01140347 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 565 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01140347 reports 0 study locations.
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.
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