Efficacy Study of Olaparib With Paclitaxel Versus Paclitaxel in Gastric Cancer Patients

Sponsor
AstraZeneca
Study ID
NCT01063517
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • olaparib — DRUG
    100mg BID oral tablet continuous
  • paclitaxel — DRUG
    iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle
  • Placebo — DRUG
    100mg BID oral tablet to match olaparib tablet

Study Details

To assess the efficacy of olaparib when given in combination with paclitaxel compared with paclitaxel alone as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first-line therapy.

Key Dates

Start date
Feb 2, 2010
Status verified
Jul 2023
Primary completion
May 11, 2012
Completion
Jun 29, 2023

Study Design

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

Arms

  • Experimental: 1
    Olaparib + paclitaxel
  • Active Comparator: 2
    paclitaxel + placebo

Primary Outcome Measure

Progression Free Survival (PFS) in the Overall Study Population [ Time Frame: Tumour assessments were carried out at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed maximum up to 27 months ]

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