Phase 1b Trial Evaluating the Safety of Volociximab in Combination With Carboplatin, Paclitaxel, and Bevacizumab in Subjects With Previously Untreated Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Phase 1b, multicenter, open-label, dose-escalation study to evaluate the safety and
tolerability of volociximab in combination with C/P + B in subjects with previously
untreated Stage IIIB/IV non-squamous NSCLC.
Subjects will be treated with the C/P + B + volociximab (V)combination for a total of 6
cycles (3 weeks/cycle). Subjects with stable disease (SD)or better per Response Evaluation
Criteria in Solid Tumors (RECIST)after the 6th cycle of combination treatment (C/P + B + V)
will be considered for further treatment in a maintenance phase with B + V at the same dose
until subject withdrawal from treatment.
Volociximab will be administered at doses ranging from 10 to 30 mg/kg every 3 weeks.
Paclitaxel, carboplatin, and bevacizumab will be administered at their registered doses for
Follow up for each subject will extend over a 90-day period following the last dose of
volociximab. End of study is defined as 90 days after the last dose of volociximab for the
last subject treated in the study.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose (MTD) of volociximab given at different doses in combination with carboplatin, paclitaxel, and bevacizumab.
Dose Limiting Toxicities (DLT) will be assessed during the first treatment cycle for each cohort
Mihail Obrocea, MD
United States: Food and Drug Administration
|Site Reference ID/Investigator# 70354||Bethesda, Maryland 20817-7847|
|Site Reference ID/Investigator# 70333||Hershey, Pennsylvania 17033-0850|
|Site Reference ID/Investigator# 70355||Greenville, South Carolina 29605|
|Site Reference ID/Investigator# 70353||Yakima, Washington 98902|