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Study With Gefitinib in Combination With Olaparib (AZD2281) Versus Gefitinib Alone

NCT01513174 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2024-06-28

Study results available
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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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Gefitinib

Gefitinib 250 mg once a day, continuously, in 28-day cycles, until progression

DRUG

Olaparib

Gefitinib 250 mg once a day, in combination with olaparib (at the recommended dose in the previous Phase Ib study) twice a day, continuously, in 28-day cycles.

Sponsors & Collaborators

  • Spanish Lung Cancer Group

    lead OTHER

Principal Investigators

  • Maria Rosario García Campelo, MD · Hospital Teresa Herrera

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01513174 on ClinicalTrials.gov