Spots Global Cancer Trial Database for Study With Gefitinib in Combination With Olaparib (AZD2281) Versus Gefitinib Alone

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Trial Identification

Brief Title: Study With Gefitinib in Combination With Olaparib (AZD2281) Versus Gefitinib Alone

Official Title: Multicenter, Randomized, Phase Ib/IIb Study to Evaluate the Efficacy and Tolerability of Gefitinib in Combination With Olaparib (AZD2281) Versus Gefitinib Alone, in Patients With EGFR Mutation Positive Advanced Non-small-cell Lung Cancer

Study ID: NCT01513174

Conditions

Non Small Cell Lung Cancer

Interventions

Gefitinib

Gefitinib plus olaparib

Study Description

Brief Summary: This is a study of gefitinib plus olaparib gefitinib in combination with olaparib (AZD2281) versus gefitinib alone, in patients with Epidermal Growth Factor Receptor (EGFR) mutation positive advanced non-small-cell lung cancer.

Detailed Description: This is a multicenter, randomized, Phase Ib/IIb, open label study to evaluate the efficacy and tolerability of gefitinib in combination with olaparib (AZD2281) versus gefitinib alone, in patients with Epidermal Growth Factor Receptor (EGFR) mutation positive advanced non-small-cell lung cancer The study will be split into 2 parts: an open label Phase I dose escalation part and a randomized controlled, open label Phase II part.