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NCT00901901 · ClinicalTrials.gov registry record · Phase 3
Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma
A Phase 3 study of Carcinoma, Hepatocellular, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 732
- Enrollment target
- 20
- Study locations
NCT00901901: Completed Phase 3 study of Carcinoma, Hepatocellular, sponsored by Bayer.
NCT00901901 is a Phase 3 study of Carcinoma, Hepatocellular that has completed, run by Bayer. The registered enrollment target is 732 participants, above the 585-participant average among 27 other Carcinoma, Hepatocellular trials with a reported enrollment target (25% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00901901, a Phase 3 study of Carcinoma, Hepatocellular, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 732 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.
Primary Outcome
Overall Survival (OS) was defined as the time from date of randomization to death due to any cause.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sorafenib (Nexavar, BAY43-9006)
- DRUG Erlotinib (Tarceva)
Study Locations (20)
Massachusetts
- - Boston
- - Boston
- - Worcester
New York
- - New York
- - Rochester
- - Valhalla
Florida
- - Gainesville
- - Miami
California
- - San Francisco
District of Columbia
- - Washington D.C.
Georgia
- - Atlanta
Hawaii
- - Honolulu
Illinois
- - Maywood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 732 participants |
| Start Date | 2009-05-21 |
| Est. Completion | 2018-05-23 |
| Phase | Phase 3 |
What the finished NCT00901901 record still lists
NCT00901901 is an interventional study that assigns participants to a tested intervention. The registered 732 participants enrollment target is mid-sized for trials with a published cap, above the 585-participant average among 27 other Carcinoma, Hepatocellular trials with a reported enrollment target (25% higher).
The record links to 1 condition, with Carcinoma, Hepatocellular appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00901901 names 20 study sites across 15 states, led by Massachusetts, New York, Florida.
Frequently Asked Questions
What is clinical trial NCT00901901 about?
NCT00901901 is a clinical study titled "Nexavar-Tarceva Combination Therapy for First Line Treatment of Patients Diagnosed With Hepatocellular Carcinoma". This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for pote...
What is the current status of trial NCT00901901?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 732 participants. The study started on 2009-05-21. Estimated completion is 2018-05-23.
What conditions does trial NCT00901901 study?
This clinical trial studies the following conditions: Carcinoma, Hepatocellular.
What interventions are being tested in trial NCT00901901?
The interventions under investigation include: Placebo (DRUG), Sorafenib (Nexavar, BAY43-9006) (DRUG), Erlotinib (Tarceva) (DRUG).
Who is sponsoring clinical trial NCT00901901?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00901901 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00901901's enrollment target sits among peer trials
732 5th of 27 higher than 23 of 27 other Carcinoma, Hepatocellular trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Hepatocellular 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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