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

Sponsor
Spanish Lung Cancer Group
Study ID
NCT01513174
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gefitinib — DRUG
    Gefitinib 250 mg once a day, continuously, in 28-day cycles, until progression
  • Olaparib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 31, 2011
Status verified
Jan 2024
Primary completion
Jul 31, 2016
Completion
Jul 31, 2016

Study Design

Enrollment
186 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control Gefitinib
    Gefitinib will be administered once daily, continuously, in 28-day cycles, as a fixed dose of 250 mg/day.
  • Experimental: Experimental: Gefitinib in combination with olaparib
    Gefitinib 250 mg once a day, in combination with olaparib (at the recommended dose in the previous Phase I study) twice a day, continuously, in 28-day cycles.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: From the date of randomization until end of follow up, up to 30 months. ]

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