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A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Carcinoma, Hepatocellular

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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 SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteCrestview Hills, Kentucky  41017
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteRichmond, Virginia  23249
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCedar Rapids, Iowa  52403
Pfizer Investigational SiteBristol, Tennessee  37620