An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00247676

Purpose

The study will consist of two parts. In Part 1 the study will start enrolling 38 patients and then further 25 patients up to a total of 63 eligible patients. If the study gives good results it can be expanded to a total of 160 patients. SU011248 will be administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg with provision for dose reduction based on tolerability. All patients will receive repeated cycles of SU011248 until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met.

After discontinuation of treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival

Condition	Intervention	Phase
Liver Neoplasms Unresectable Hepatocellular Carcinoma	Drug: Sunitinib	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Official Title:	An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Overall confirmed objective response rate [ Time Frame: From screening until at least 28 days beyond discontinuation of study treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Benefit Rate, Duration of Response, Progression-free survival; Time to progression; Overall survival; Probability of survival at 1 year, safety, pk, biomarkers [ Time Frame: From screening until disease progression or discontinuation of study. ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	February 2006
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Sunitinib Sunitinib 50 mg by oral capsule, daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.

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
Patients must present with disease not amenable to curative surgery (i.e. either hepatectomy, or liver transplant).
Evidence of measurable disease by radiographic technique
Adequate organ function.

Exclusion Criteria:

Prior treatment with any systemic treatment for liver cancer
Presence of clinically relevant ascites
Severe hemorrhage <4 weeks of starting study treatment.
Diagnosis of second malignancy within last 3 years
History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
Known HIV
Serious acute or chronic illness
Current treatment on another clinical trial
Pregnant or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247676

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

Locations

France
Pfizer Investigational Site	Completed
SAINT HERRBLAIN CEDEX, France, 44805
Pfizer Investigational Site	Active, not recruiting
Clichy Cedex, France, 92118
Pfizer Investigational Site	Recruiting
Rennes cedex, France, 4422935062
Korea, Republic of
Pfizer Investigational Site	Completed
Seoul, Korea, Republic of, 135-710
Pfizer Investigational Site	Completed
Seoul, Korea, Republic of, 138-736
Pfizer Investigational Site	Completed
Seoul, Korea, Republic of, 152-703
Pfizer Investigational Site	Completed
Seoul, Korea, Republic of, 110-744
Taiwan
Pfizer Investigational Site	Active, not recruiting
Taipei, Taiwan, 110

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:	A6181055
Study First Received:	November 1, 2005
Last Updated:	January 18, 2009
ClinicalTrials.gov Identifier:	NCT00247676 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Liver neoplasms, sunitinib, Phase 2

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Sunitinib
Carcinoma, Hepatocellular

Gastrointestinal Neoplasms
Hepatocellular Carcinoma
Adenocarcinoma
Angiogenesis Inhibitors
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Carcinoma, Hepatocellular
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma

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

ClinicalTrials.gov processed this record on September 10, 2009