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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: sorafenib; Drug: sunitinib malate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00699374

A6181170

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,075 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,075 participants in 2 patient groups

Arm A

Experimental group

Description:

sunitinib arm

Treatment:

Drug: sunitinib malate

Arm B

Active Comparator group

Description:

sorafenib arm

Treatment:

Drug: sorafenib