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

Phase 1

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: M200 (Volociximab), Carboplatin, Paclitaxel

• Registration Number: NCT00654758
• Lead Sponsor: AbbVie

Brief Summary

The primary purpose of this study is to examine the safety of volociximab in combination with a standard treatment of carboplatin and paclitaxel in subjects previously untreated with chemotherapy for advanced stage (IIIB/IV) non-small cell lung cancer (NSCLC).

Detailed Description

This Phase 1b, multicenter, open-label, dose-escalation study will evaluate the safety and pharmacokinetics (PK) of volociximab in combination with carboplatin and paclitaxel (C/P) as first-line treatment in subjects with Stage IIIB or IV non-small cell lung cancer (NSCLC). Volociximab doses of 10, 20, and 30 mg/kg (or 15 mg/kg if 20 mg/kg is not tolerable) with carboplatin/paclitaxel chemotherapy will be tested for determining the maximum tolerated dose (MTD). Subjects will be dosed once very 3 weeks for up to 6 cycles.

Volociximab is a high-affinity, chimeric monoclonal antibody that specifically binds to α5β1 integrin, a cell-surface receptor for fibronectin. Volociximab blocks the binding of α5β1 to fibronectin, thereby inhibiting a pivotal interaction required for angiogenesis.

More than 170 subjects with various solid tumor types have received volociximab in Phase 1 and Phase 2 single and combination studies. At the doses tested, there has not been a dose limiting toxicity (DLT) or a maximum tolerated dose (MTD) defined.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-08
• Study First Posted: 2008-04-09
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2012-04
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	M200 (Volociximab), Carboplatin, Paclitaxel	Escalating doses of volociximab at 10, 20, and 30 (or 15) mg/kg with carboplatin and paclitaxel.

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose (MTD) of volociximab given at different doses in combination with carboplatin and paclitaxel	Dose escalation phase of the trial

Secondary Outcome Measures

Name	Time	Method
Efficacy of volociximab in combination with carboplatin/paclitaxel	Approximately 2.5 years
Pharmacokinetics of volociximab	Approximately 2.5 years