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NCT02435433 · ClinicalTrials.gov registry record · Phase 3
A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein
A Phase 3 study of Hepatocellular Carcinoma, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 399
- Enrollment target
- 20
- Study locations
NCT02435433: Completed Phase 3 study of Hepatocellular Carcinoma, sponsored by Eli Lilly and Company.
NCT02435433 is a Phase 3 study of Hepatocellular Carcinoma that has completed, run by Eli Lilly and Company. The registered enrollment target is 399 participants, above the 255-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (56% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02435433, a Phase 3 study of Hepatocellular Carcinoma, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 399 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and efficacy of ramucirumab in participants with hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein. Participants will be randomized to ramucirumab or placebo in a 2:1 ratio (Main Global Cohort and China Maximized Extended Enrollment \[MEE\] Cohort). Participants may also receive ramucirumab if eligible to be enrolled in Open-Label Expansion (OLE) Cohort.
Primary Outcome
OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ramucirumab
Study Locations (20)
Other
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Kurralta Park
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Woodville
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Linz
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Vienna
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Brussels
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Liège
- Fundação PIO XII - Barretos
- "For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician." - Barretos
- Cenantron - Centro Avançado de Tratamento Oncológico - Belo Horizonte
- Associação Hospital de Caridade Ijuí - Ijuí
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Porto Alegre
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - São Paulo
California
- Pacific Hematology and Oncology Associates - Daly City
- UCLA Medical Center - Los Angeles
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Iowa
- University of Iowa Hospital - Iowa City
Massachusetts
- Massachusetts General Hospital - Boston
New York
- Mount Sinai Medical Center - New York
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Oregon
- OREGON HEALTH and SCIENCE UNIVERSITY - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 399 participants |
| Start Date | 2015-07-20 |
| Est. Completion | 2021-11-19 |
| Phase | Phase 3 |
What the finished NCT02435433 record still lists
NCT02435433 is an interventional study that assigns participants to a tested intervention. The registered 399 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 (56% 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.
NCT02435433 names 20 study sites across 8 states, led by Other, California, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT02435433 about?
NCT02435433 is a clinical study titled "A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein". The purpose of this study is to evaluate the safety and efficacy of ramucirumab in participants with hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein. Participants will be randomized to ramucirumab or placebo in a 2:1 ratio (Main Global Cohort and China Maximized Extended Enrol...
What is the current status of trial NCT02435433?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 399 participants. The study started on 2015-07-20. Estimated completion is 2021-11-19.
What conditions does trial NCT02435433 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma.
What interventions are being tested in trial NCT02435433?
The interventions under investigation include: Placebo (DRUG), Ramucirumab (DRUG).
Who is sponsoring clinical trial NCT02435433?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02435433 being conducted?
This trial has 20 study locations across California, District of Columbia, Iowa, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02435433's enrollment target sits among peer trials
399 32nd of 145 higher than 114 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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