A Phase 1b Study With Volociximab in Combination With Carboplatin, Paclitaxel, and Bevacizumab in First-line, Advanced Non-small Cell Lung Cancer (NSCLC)
|ClinicalTrials.gov Identifier: NCT00666692|
Recruitment Status : Completed
First Posted : April 25, 2008
Last Update Posted : April 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: M200 (Volociximab), Carboplatin, Paclitaxel, Bevacizumab||Phase 1|
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 this combination.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||April 2008|
|Primary Completion Date :||October 2008|
|Study Completion Date :||October 2008|
Escalating doses of volociximab at 10, 20, and 30 mg/kg with carboplatin, paclitaxel, and bevacizumab
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.
Other Name: Volociximab (M200)
- To determine the maximum tolerated dose (MTD) of volociximab given at different doses in combination with carboplatin, paclitaxel, and bevacizumab. [ Time Frame: Dose Limiting Toxicities (DLT) will be assessed during the first treatment cycle for each cohort ]
- 1) Pharmacokinetics of volociximab 2) Efficacy of volociximab in combination with carboplatin/paclitaxel and bevacizumab. [ Time Frame: Throughout study period ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00666692
|United States, Maryland|
|Site Reference ID/Investigator# 70354|
|Bethesda, Maryland, United States, 20817-7847|
|United States, Pennsylvania|
|Site Reference ID/Investigator# 70333|
|Hershey, Pennsylvania, United States, 17033-0850|
|United States, South Carolina|
|Site Reference ID/Investigator# 70355|
|Greenville, South Carolina, United States, 29605|
|United States, Washington|
|Site Reference ID/Investigator# 70353|
|Yakima, Washington, United States, 98902|
|Study Director:||Mihail Obrocea, MD||Abbott|