Status:
COMPLETED
An International Phase 2 Study Of SU011248 In Patients With Inoperable Liver Cancer
Lead Sponsor:
Pfizer
Conditions:
Liver Neoplasms
Unresectable Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 human immunodeficiency virus (HIV)
- Serious acute or chronic illness
- Current treatment on another clinical trial
- Pregnant or breastfeeding
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00247676
Start Date
February 1 2006
End Date
February 1 2009
Last Update
February 18 2010
Active Locations (8)
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1
Pfizer Investigational Site
Clichy, France, 92118
2
Pfizer Investigational Site
Rennes, France, 4422935062
3
Pfizer Investigational Site
Saint Herrblain Cedex, France, 44805
4
Pfizer Investigational Site
Seoul, South Korea, 110-744