NCT01039948

A Phase 1b/2 Study in Asian Subjects With Non-Small Cell Lung Cancer

A Phase 1b/2 Study of AV-299 (Formerly SCH 900105) in Combination With Gefitinib in Asian Subjects With Non-Small Cell Lung Cancer (P06162)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: AVEO Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Non-Small Cell-Lung
• Lung Neoplasms
• Lung Cancer
• Respiratory Tract Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	AV-299 + gefitinib	AV-299 is a humanized anti-HGF IgG1 monoclonal antibody directed against free HGF, ligand for c-Met tyrosine kinase receptor.
DRUG	Gefitinib	Gefitinib is a small molecule (drug) which selectively inhibits epidermal growth factor receptor's (EGFR) tyrosine kinase domain.

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2009-12-25
• Last updated: 2015-04-08

Locations

26 sites across 7 countries: Hong Kong, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand