A Phase 1b/2 Study in Asian Subjects With Non-Small Cell Lung Cancer
Status:
Completed
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
Summary
During Phase 1b portion, there will be a dose-escalation of AV-299 (formerly SCH 900105) in
combination with the recommended dose of gefitinib in subjects with NSCLC or advanced solid
tumor. The objective is to determine the safety, tolerability, dose limiting toxicity (DLT)
and recommended Phase 2 dose (RP2D) in combination with gefitinib for the Phase 2 portion.
The Phase 2 is an open-label, 2-arm, randomized study designed to compare the combination of
AV-299 (formerly SCH900105) and gefitinib versus gefitinib alone in clinically selected Asian
subjects with previously untreated lung adenocarcinoma who have a high likelihood of
harboring activating EGFR mutations. Subjects who progress after initial disease control in
the gefitinib alone arm may crossover to the combination arm.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
AVEO Pharmaceuticals, Inc.
Treatments:
Gefitinib Molecular Mechanisms of Pharmacological Action