A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma
18 Years
N/A
Both
Carcinoma, Hepatocellular
Trial Information
A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma
This study was terminated on April 22th, 2010, based on a higher incidence of serious
adverse events in the sunitinib arm compared to the sorafenib arm, and the fact that
sunitinib did not meet the criteria to demonstrate that it was either superior or
non-inferior to sorafenib in the survival of patients with advanced hepatocellular cancer.
Patients on sunitinib who are judged by the investigator as receiving clinical benefit may
chose to remain on study and continue treatment with sunitinib until clinical benefit as per
the investigator's judgment.
Inclusion Criteria:
- Histologically-confirmed diagnosis of hepatocellular carcinoma
- presence of measurable disease by radiographic imaging
- Child-Pugh class A
- ECOG PS 0 or 1
- adequate organ function.
Exclusion Criteria:
- Prior treatment with any systemic treatment for hepatocellular carcinoma
- prior local treatment within 4 weeks from entry
- presence of clinically relevant ascites
- severe hemorrhage <4 weeks of starting study treatment
- known HIV or serious acute or chronic illness
- current treatment on another clinical trial
- pregnancy or breastfeeding
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival (OS)
Outcome Description:
Overall survival is the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
Outcome Time Frame:
Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A6181170
NCT ID:
NCT00699374
Start Date:
July 2008
Completion Date:
December 2011
Related Keywords:
- Carcinoma, Hepatocellular
- sunitinib
- phase 3
- randomized
- hepatocellular
- liver
- Carcinoma
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Atlanta, Georgia 30342 |
| Pfizer Investigational Site | Crestview Hills, Kentucky 41017 |
| Pfizer Investigational Site | Cincinnait, Ohio 45236 |
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | Richmond, Virginia 23249 |
| Pfizer Investigational Site | Federal Way, Washington 98003 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
| Pfizer Investigational Site | Cedar Rapids, Iowa 52403 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
