Status:
COMPLETED
A Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST)
Lead Sponsor:
Pfizer
Conditions:
Gastrointestinal Stromal Tumors
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Phase I;To investigate the clinically recommended dose of Sunitinib malate (SU011248) following multiple oral dosing in the first cycle (4 consecutive weeks and 2 weeks rest) by reviewing the safety a...
Eligibility Criteria
Inclusion
- Patients with histologically-confirmed metastatic or unresectable gastrointestinal stromal tumor (GIST).
- Patients previously treated with imatinib mesylate.
Exclusion
- Patients who have not recovered from the acute toxic effects of previous antineoplastic therapy or treatment with imatinib mesylate.
- Any tumor therapy for gastrointestinal stromal tumor (GIST) discontinued less than 4 weeks prior to starting study treatment. Imatinib mesylate discontinued less than 2 weeks prior to starting therapy.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00457743
Start Date
January 1 2005
End Date
August 1 2008
Last Update
November 13 2009
Active Locations (4)
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1
Pfizer Investigational Site
Kashiwa, Chiba, Japan
2
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
3
Pfizer Investigational Site
Suita, Osaka, Japan
4
Pfizer Investigational Site
Chuo-ku, Tokyo, Japan