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Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III

Treatment

Active

18 and over

Pharmaceutical / Industry

A6181170
NCT00699374

Trial Description

Summary

The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be given until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of study treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Pfizer Incorporated

Pfizer CT.gov Call Center

Study Director

Pfizer Oncology Clinical Trial Information Service		Ph: 1-877-369-9753
		Email: PfizerCancerTrials@emergingmed.com

Pfizer CT.gov Call Center

Ph: 1-800-718-1021

Trial Sites

Australia

Victoria

Parkville

Pfizer Investigational Site

Malaysia

Kuala Lumpur

Pfizer Investigational Site

Philippines

Quezon City

Pfizer Investigational Site

Republic of Korea

Chonju

Pfizer Investigational Site

Daegu

Pfizer Investigational Site

Goyang-si

Pfizer Investigational Site

Hwasun-gun

Pfizer Investigational Site

Seoul

Pfizer Investigational Site

Taiwan, Province of China

Changhua

Pfizer Investigational Site

Chiayi County

Pfizer Investigational Site

Kuei-Shan Hsiang

Pfizer Investigational Site

Tainan

Pfizer Investigational Site

Taipei

Pfizer Investigational Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00699374
Information obtained from ClinicalTrials.gov on October 08, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.