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

Sponsored by:	Pfizer
Information provided by:	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:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment:	1200
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm A: Experimental 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.
Arm B: Active Comparator 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.

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

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Show 165 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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181170
Study First Received:	June 16, 2008
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00699374 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

sunitinib, phase 3, randomized, hepatocellular, liver

Study placed in the following topic categories:

Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Angiogenesis Inhibitors
Protein Kinase Inhibitors
Carcinoma
Liver Neoplasms

Digestive System Diseases
Sunitinib
Gastrointestinal Neoplasms
Adenocarcinoma
Hepatocellular Carcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Carcinoma, Hepatocellular
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

Carcinoma
Liver Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Sunitinib
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on August 28, 2009