A Phase 1b Study With Volociximab in Combination With Carboplatin and Paclitaxel in First-line, Advanced Non-Small Cell Lung Cancer (NSCLC)

PHASE1CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

May 31, 2010

Study Completion Date

May 31, 2010

Conditions
Non-small Cell Lung Cancer
Interventions
DRUG

M200 (Volociximab), Carboplatin, Paclitaxel

Volociximab will be administered via IV infusion at 10, 20, and 15 or 30 mg/kg with an additional loading dose in the 10, 20, and 15 mg/kg dose levels during the first cycle. Volociximab will be given for at least 6 cycles (3 weeks/cycle) and subjects who have stable disease at the end of 6 cycles may continue to receive volociximab alone until disease progression. Carboplatin is administered via IV infusion and dosed based on the Calvert formula (with a target area AUC of 6 mg/mL/min) for up to 6 cycles (3 weeks/cycle). Paclitaxel is administered via IV infusion and dosed at 200 mg/m2 for up to 6 cycles (3 weeks/cycle). All three drugs, when given in combination, will be infused on the same day in the following sequence: volociximab, paclitaxel, carboplatin.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AbbVie

INDUSTRY