Phase 1 Study Of Sunitinib (SU011248) In Combination With Pemetrexed In Patients With Advanced Solid Malignancies In Japan
20 Years
N/A
Both
Neoplasm, Malignant
Trial Information
Phase 1 Study Of Sunitinib (SU011248) In Combination With Pemetrexed In Patients With Advanced Solid Malignancies In Japan
Inclusion Criteria:
- Patients with a diagnosis of a solid malignancy that is refractory to standard
therapy or for which no standard therapy exists.
- Patients 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
okey).
- Hypertension that cannot be controlled by medications.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants With Adverse Events
Outcome Description:
Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , dose limiting toxicities (DLT), serious adverse events, adverse events resulted in discontinuation.
Outcome Time Frame:
End of study (up to individual discontinuation)
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
A6181165
NCT ID:
NCT00732992
Start Date:
August 2008
Completion Date:
November 2009
Related Keywords:
- Neoplasm, Malignant
- Solid tumor
- malignancy
- sunitinib
- pemetrexed
- phase 1
- neoplasms
- Neoplasms
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