The main purpose of this study is to evaluate the overall safety and maximum dose of CI 1033 in combination with paclitaxel and carboplatin in patients with NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Park Ridge, Illinois, United States
Pfizer Investigational Site
Skokie, Illinois, United States
Pfizer Investigational Site
Louisville, Kentucky, United States
The primary objective is to evaluate the overall safety profile, including dose-limiting toxicities and the maximum tolerated dose, of CI 1033 in combination with paclitaxel (225 mg/m2) and carboplatin (area under the concentration time curve [AUC] of 6
To determine the recommended Phase 2 dose of CI 1033 in combination with paclitaxel and carboplatin for patients with advanced NSCLC; to further define the safety profile of the recommended Phase 2 dose combination in an expanded cohort (22 patients)
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Pfizer Investigational Site
Louisville, Kentucky, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Hamilton, Ontario, Canada