A Phase 1 Study Of SU011248 And Gemcitabine In Patients With Advanced Solid Tumors
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Solid Tumors
Both
Solid Tumors
Trial Information
A Phase 1 Study Of SU011248 And Gemcitabine In Patients With Advanced Solid Tumors
Inclusion Criteria:
- Patients with diagnosis of a solid cancer which is not responsive to standard therapy
or for which no standard therapy exists
- Patient has good performance status (ECOG 0 or 1)
Exclusion Criteria:
- Prior treatment with either gemcitabine or SU011248
- Hypertension that cannot be controlled by medications
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the maximally tolerated dose of SU011248 (dosed on Schedule 4/2 or 2/1) when given in combination with gemcitabine
Outcome Time Frame:
From screening until at least 28 days beyond discontinuation of study treatment
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A6181041
NCT ID:
NCT00615446
Start Date:
March 2005
Completion Date:
May 2009
Related Keywords:
- Solid Tumors
- solid tumor malignancy, SU011248, sunitinib, neoplasms
- Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | North Adams, Massachusetts 01247 |
