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NCT01210495 · ClinicalTrials.gov registry record · Phase 2
Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma
A Phase 2 study of Hepatocellular Carcinoma, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 224
- Enrollment target
- 20
- Study locations
NCT01210495: Completed Phase 2 study of Hepatocellular Carcinoma, sponsored by Pfizer.
NCT01210495 is a Phase 2 study of Hepatocellular Carcinoma that has completed, run by Pfizer. The registered enrollment target is 224 participants, below the 256-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (12% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01210495, a Phase 2 study of Hepatocellular Carcinoma, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 224 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study is designed to demonstrate that axitinib plus best supportive care is superior to placebo plus best supportive care in prolonging survival in patients with advanced hepatocellular carcinoma.
Primary Outcome
OS was defined as the time from the date of randomization to the date of death due to any cause. OS (in months) was calculated as (date of death - first randomization date +1)/30.4. For participants still alive at the time of the analysis, the OS time was censored on the last date they were known to be alive. All participants were followed up for survival at least every 3 months after discontinuing study treatment until at least two years after randomization of the last participant.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Axitinib (AG-013736)
- OTHER Best Supportive Care
Study Locations (20)
California
- Alta Bates Summit Comprehensive Cancer Center - Berkeley
- UCSD Medical Center- La Jolla - La Jolla
- Moores UCSD Cancer Center - La Jolla
- University of California Irvine Medical Center - Orange
- UCSD Medical Center- Hillcrest - San Diego
Florida
- Florida Hospital Transplant Center, Liver Unit - Orlando
- Moffitt Cancer Center & Research Institute - Tampa
Nevada
- Comprehensive Cancer Centers of Nevada - Las Vegas
- Comprehensive Cancer Centers of Nevada - Las Vegas
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
- Penn Presbyterian Medical Center - Philadelphia
Other
- Universitair Ziekenhuis Gent - Ghent
- CHC Clinique Saint-Joseph - Liège
Jiangsu
- Nanjing Bayi Hospital - Nanjing
- Jiang Su Cancer Hospital - Nanjing
Michigan
- University of Michigan - Ann Arbor
Nebraska
- Nebraska Methodist Hospital - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2010-12-06 |
| Est. Completion | 2016-12-20 |
| Phase | Phase 2 |
What the finished NCT01210495 record still lists
NCT01210495 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, below the 256-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (12% lower).
The record links to 1 condition, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01210495 names 20 study sites across 11 states, led by California, Florida, Nevada.
Frequently Asked Questions
What is clinical trial NCT01210495 about?
NCT01210495 is a clinical study titled "Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma". The study is designed to demonstrate that axitinib plus best supportive care is superior to placebo plus best supportive care in prolonging survival in patients with advanced hepatocellular carcinoma.
What is the current status of trial NCT01210495?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 224 participants. The study started on 2010-12-06. Estimated completion is 2016-12-20.
What conditions does trial NCT01210495 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma.
What interventions are being tested in trial NCT01210495?
The interventions under investigation include: Placebo (DRUG), Axitinib (AG-013736) (DRUG), Best Supportive Care (OTHER).
Who is sponsoring clinical trial NCT01210495?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01210495 being conducted?
This trial has 20 study locations across California, Florida, Michigan, Nebraska, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01210495's enrollment target sits among peer trials
224 41st of 145 higher than 105 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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