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Study to Evaluate SCH 900105 in Combination With Gefitinib in Subjects With Non-Small Cell Lung Cancer (NSCLC) (Study P06162AM1)

2014-07-23 21:11:16 | BioPortfolio

Summary

During Phase 1b portion, there will be a dose-escalation of SCH 900105 in combination with the recommended dose of gefitinib in subjects with NSCLC or advanced solid tumors. 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 SCH 900105 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

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Carcinoma, Non-Small-Cell Lung

Intervention

SCH 900105, Gefitinib

Location

Investigational Site 1
Singapore
Singapore

Status

Recruiting

Source

Schering-Plough

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:16-0400

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