Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00699374

Purpose

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.

Condition	Intervention	Phase
Carcinoma, Hepatocellular	Drug: sunitinib malate Drug: sorafenib	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Sorafenib Sunitinib malate Sorafenib tosylate Sunitinib Malic acid

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Overall Survival [ Time Frame: From screening/baseline to patient death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression Free Survival [ Time Frame: From Screening/baseline until patient progression or death ] [ Designated as safety issue: No ]
Time to Tumor Progression [ Time Frame: From screening/baseline until patient progression ] [ Designated as safety issue: No ]
Safety (adverse events and laboratory abnormalities) [ Time Frame: From screening/baseline to end of study treatment ] [ Designated as safety issue: No ]
Health Status [ Time Frame: From baseline to end of study treatment ] [ Designated as safety issue: No ]

Enrollment:	1075
Study Start Date:	July 2008
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm A sunitinib arm	Drug: sunitinib malate 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. Other Name: Sutent®
Active Comparator: Arm B sorafenib arm	Drug: sorafenib 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. Other Name: Nexavar®

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699374

Show 171 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Koeberle D, Montemurro M, Samaras P, Majno P, Simcock M, Limacher A, Lerch S, Kovàcs K, Inauen R, Hess V, Saletti P, Borner M, Roth A, Bodoky G. Continuous Sunitinib Treatment in Patients with Advanced Hepatocellular Carcinoma: A Swiss Group for Clinical Cancer Research (SAKK) and Swiss Association for the Study of the Liver (SASL) Multicenter Phase II Trial (SAKK 77/06). Oncologist. 2010 Mar 4; [Epub ahead of print]

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00699374 History of Changes
Other Study ID Numbers:	A6181170
Study First Received:	June 16, 2008
Last Updated:	January 26, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

sunitinib
phase 3
randomized
hepatocellular
liver

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib

Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012