A Phase 1 Safety And Pharmacokinetic Study Of SU011248 And Capecitabine In Patients With Advanced Solid Tumors
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Solid Tumors, Breast Cancer, Neoplasms
Both
Solid Tumors, Breast Cancer, Neoplasms
Trial Information
A Phase 1 Safety And Pharmacokinetic Study Of SU011248 And Capecitabine 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 SU011248 or capecitabine.
- 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 continuously or on a 4/2 or 2/1 Schedule) when given in combination with capecitabine.
Outcome Time Frame:
From Screening until disease progression or discontinuation of the study
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:
A6181044
NCT ID:
NCT00618124
Start Date:
May 2005
Completion Date:
July 2008
Related Keywords:
- Solid Tumors
- Breast Cancer
- Neoplasms
- solid tumor malignancy, SU011248, sunitinib, capecitabine, Phase 1
- Breast Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Carmel, Indiana 46032 |
| Pfizer Investigational Site | Santa Fe, New Mexico 87505 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
