Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats

Part of paid clinical trials in West Hollywood, California.

Sponsor
AstraZeneca
Study ID
NCT01078662
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Tumours
  • Breast
  • Ovarian
  • Pancreatic
  • Prostate

Eligibility Criteria

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

Interventions

Study Details

To assess the efficacy of oral olaparib in patients with advanced cancer who have a confirmed genetic BRCA1 and/or BRCA2 mutation, by assessment of tumour response

Key Dates

Start date
Feb 21, 2010
Status verified
Aug 2025
Primary completion
Jul 31, 2012
Completion
Aug 12, 2024

Study Design

Enrollment
298 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator. Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions.

Primary Outcome Measure

Tumour Response Rate [ Time Frame: Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteWest HollywoodCalifornia90048-
Research SitePhiladelphiaPennsylvania19104-

Find similar trials in West Hollywood, CA

By research site
Research Site· West Hollywood, CAResearch Site· Philadelphia, PA

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