Trial Information
A Phase I Study Of Sunitinib Malate In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer
Inclusion Criteria:
- confirmed diagnosis of stomach cancer
- advanced stomach cancer stage IV
- adequate blood chemistry, blood counts and kidney function
- willing to participate to study requirements and to sign an informed consent document
Exclusion Criteria:
- prior chemotherapy for stomach cancer in its advanced stage
- excessive toxicities related to prior therapies
- pregnant or breastfeeding patients
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 Participants With First-cycle Dose Limiting Toxicities (DLTs)
Outcome Description:
The incidence of DLTs assessed during the first cycle (21 days).
Outcome Time Frame:
Cycle 1 (Baseline to Day 21)
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A6181128
NCT ID:
NCT00555672
Start Date:
August 2008
Completion Date:
August 2010
Related Keywords:
- Stomach Neoplasms
- Neoplasms
- Stomach Neoplasms