A Phase 1b Trial to Evaluate the Safety and Pharmacokinetics of Volociximab (M200) in Combination With Carboplatin and Paclitaxel in Subjects With Previously Untreated Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC)
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.
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 and paclitaxel
Dose escalation phase of the trial
Mihail Obrocea, MD
United States: Food and Drug Administration
|Site Reference ID/Investigator# 70404||Hershey, Pennsylvania 17033-0850|