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
Public ClinicalTrials.gov record NCT01140347. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Phase 3 Study of Ramucirumab (IMC-1121B) Drug Product and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma Following First-Line Therapy With Sorafenib (REACH)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01140347
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 565 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2010 (Type not available)
- Primary completion
- Mar 2014 (Actual)
- Completion
- Mar 2015 (Actual)
- Last update posted
- Dec 28, 2015
2010 – 2015
United States locations
- U.S. sites
- 18
- U.S. states
- 16
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| ImClone Investigational Site | Orange | California | 92868 | — |
| ImClone Investigational Site | San Francisco | California | 94115 | — |
| ImClone Investigational Site | New Haven | Connecticut | 06520 | — |
| ImClone Investigational Site | Jacksonville | Florida | 32207 | — |
| ImClone Investigational Site | New Orleans | Louisiana | 70112 | — |
| ImClone Investigational Site | Boston | Massachusetts | 02111 | — |
| ImClone Investigational Site | Worcester | Massachusetts | 01655 | — |
| ImClone Investigational Site | Ann Arbor | Michigan | 48109 | — |
| ImClone Investigational Site | St Louis | Missouri | 63110 | — |
| ImClone Investigational Site | Newark | New Jersey | 07103 | — |
| ImClone Investigational Site | New York | New York | 10029 | — |
| ImClone Investigational Site | Winston-Salem | North Carolina | 27157 | — |
| ImClone Investigational Site | Dayton | Ohio | 45420 | — |
| ImClone Investigational Site | Philadelphia | Pennsylvania | 19141 | — |
| ImClone Investigational Site | Charleston | South Carolina | 29414 | — |
| ImClone Investigational Site | Lubbock | Texas | 79415 | — |
| ImClone Investigational Site | Seattle | Washington | 98109 | — |
| ImClone Investigational Site | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 128 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01140347, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 28, 2015 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01140347 live on ClinicalTrials.gov.