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	Drug: SU011248	Phase II

Further study details as provided by Pfizer:

Primary Outcomes: Overall confirmed objective response rate
Secondary Outcomes: Clinical Benefit Rate, Duration of Response, Progression-free survival; Time to progression; Overall survival; Probability of survival at 1 year, safety, pk, biomarkers
Expected Total Enrollment:  160

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00247676

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A6181055
Last Updated:  December 9, 2005
Record first received:  November 1, 2005
ClinicalTrials.gov Identifier:  NCT00247676
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10