Phase I Study Of SU011248 In Combination With Pemetrexed, Pemetrexed/Cisplatin And Pemetrexed/Carboplatin In Patients With Advanced Solid Malignancies
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Neoplasms
Both
Neoplasms
Trial Information
Phase I Study Of SU011248 In Combination With Pemetrexed, Pemetrexed/Cisplatin And Pemetrexed/Carboplatin In Patients With Advanced Solid Malignancies
Inclusion Criteria:
- Patients with a diagnosis of a solid cancer which is not responsive to standard
therapy or for which no standard therapy exists.
- Patient has a good performance status (ECOG 0 or 1).
Exclusion Criteria:
- Prior treatment with either pemetrexed or SU011248.
- Coughing up blood within 4 weeks before starting study treatment (small amounts
okay).
- 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 maximally tolerated dose of SU011248 (dosed continuously or on a 2/1 Schedule) when given in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin.
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:
A6181084
NCT ID:
NCT00528619
Start Date:
November 2006
Completion Date:
April 2010
Related Keywords:
- Neoplasms
- Solid tumor malignancy
- non-small cell lung cancer
- sunitinib
- pemetrexed
- Phase 1
- Mesothelioma
- Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Aurora, Colorado 80012 |
