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Study Of Sunitinib Malate Ver...

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

Last Updated: 2013-01-14

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1075 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

sunitinib arm

Group Type EXPERIMENTAL

sunitinib malate

Intervention Type DRUG

sunitinib capsules at starting dose of 37.5 mg PO daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sunitinib dosing interruptions and/or reductions are allowed based on patient tolerability.

Arm B

sorafenib arm

Group Type ACTIVE_COMPARATOR

sorafenib

Intervention Type DRUG

sorafenib tablets at starting dose of 400 mg PO twice daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sorafenib dosing interruptions and/or reductions are allowed based on patient tolerability.

Interventions

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sunitinib malate

Intervention Type DRUG

sorafenib

Intervention Type DRUG

Other Intervention Names

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Sutent® Nexavar®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Fountain Valley, California, United States

Site Status

Pfizer Investigational Site

La Jolla, California, United States

Site Status

Pfizer Investigational Site

La Jolla, California, United States

Site Status

Pfizer Investigational Site

Orange, California, United States

Site Status

Pfizer Investigational Site

San Diego, California, United States

Site Status

Pfizer Investigational Site

Miami, Florida, United States

Site Status

Pfizer Investigational Site

Ringgold, Georgia, United States

Site Status

Pfizer Investigational Site

Iowa City, Iowa, United States

Site Status

Pfizer Investigational Site

Crestview Hills, Kentucky, United States

Site Status