Study to Assess The Efficacy and Safety of a PARP Inhibitor For The Treatment of BRCA-positive Advanced Breast Cancer

Part of paid clinical trials in West Hollywood, California.

Sponsor
AstraZeneca
Study ID
NCT00494234
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Olaparib — DRUG
    Participants will receive capsules of olaparib orally as stated in arm description.

Study Details

The purpose of the study is to see if the drug KU-0059436 (olaparib) is effective and well tolerated in treating participants with measurable breast cancer gene (BRCA)1- or BRCA2-positive advanced breast cancer and for whom no curative therapeutic option exists.

Key Dates

Start date
Jun 15, 2007
Status verified
Jan 2024
Primary completion
Feb 27, 2009
Completion
Dec 21, 2022

Study Design

Enrollment
54 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib 100 mg
    Participants will receive two 50 mg capsules in the morning and two 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion is met.
  • Experimental: Olaparib 400 mg
    Participants will receive eight 50 mg capsules in the morning and eight 50 mg capsules in the evening in 28-days cycle until confirmed disease progression, continuous treatment interruption, unacceptable toxicity or any other discontinuation criterion is met.

Primary Outcome Measure

Confirmed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria [ Time Frame: Baseline (Days -28 to 0), Day 1 of Cycle 3, thereafter every alternate cycles until study termination or withdrawal (approximately up to 2 years) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteWest HollywoodCalifornia90048-
Research SiteBostonMassachusetts02115-

Find similar trials in West Hollywood, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Research Site· West Hollywood, CAResearch Site· Boston, MA

Related Studies