A Phase I/II Study of Sunitinib Malate (SU011248) In The Treatment of Patients With Malignant Gastrointestinal Stromal Tumor (GIST) Previously Treated by Imatinib Mesylate.
Phase 1/Phase 2
20 Years
75 Years
20 Years
75 Years
Not Enrolling
Both
Gastrointestinal Stromal Tumors
Both
Gastrointestinal Stromal Tumors
Trial Information
A Phase I/II Study of Sunitinib Malate (SU011248) In The Treatment of Patients With Malignant Gastrointestinal Stromal Tumor (GIST) Previously Treated by Imatinib Mesylate.
Inclusion Criteria:
- Patients with histologically-confirmed metastatic or unresectable gastrointestinal
stromal tumor (GIST).
- Patients previously treated with imatinib mesylate.
Exclusion Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Subjects With Dose Limiting Toxicities (DLT)
Outcome Time Frame:
Cycle 1 (Baseline to Week 6)
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
A6181045
NCT ID:
NCT00457743
Start Date:
January 2005
Completion Date:
August 2008
Related Keywords:
- Gastrointestinal Stromal Tumors
- Evaluate of RTD for Japanese GIST patients
- Gastrointestinal Stromal Tumors
Name | Location |
|---|
