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

PHASE1CompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

October 31, 2008

Study Completion Date

October 31, 2008

Conditions
Non-small Cell Lung Cancer
Interventions
DRUG

M200 (Volociximab), Carboplatin, Paclitaxel, Bevacizumab

Volociximab will be administered via IV infusion once every three week at 10, 20, and 15 or 30 mg/kg with an additional loading dose in the 10, 20, and 15 mg/kg dose levels on Day 8 of the first cycle. Volociximab will be given for up to 6 cycles (3 weeks/cycle). Subjects who have stable disease or better and subjects who have disease that is not progressing 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 four drugs, when given in combination, will be infused on the same day in the following sequence: volociximab, paclitaxel, carboplatin.

Trial Locations (4)

29605

Site Reference ID/Investigator# 70355, Greenville

98902

Site Reference ID/Investigator# 70353, Yakima

20817-7847

Site Reference ID/Investigator# 70354, Bethesda

17033-0850

Site Reference ID/Investigator# 70333, Hershey

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Abbott

INDUSTRY