Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status

Part of paid clinical trials in Los Angeles, California.

Sponsor
AstraZeneca
Study ID
NCT00912743
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • olaparib — DRUG
    400 mg po bid continuously

Study Details

This study is being carried out to see if the new drug, olaparib (AZD2281), can effectively and safely treat advanced large bowel cancer. The primary goal of this clinical trial is to determine whether olaparib will have a beneficial effect on the patient's cancer by causing a response and increasing the time it takes for the cancer to progress.

Key Dates

Start date
May 31, 2009
Status verified
Sep 2016
Primary completion
Mar 31, 2012
Completion
Mar 31, 2012

Study Design

Enrollment
33 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    MSI - H arm

Primary Outcome Measure

Tumour Response [ Time Frame: From baseline, i.e. up to 28 days before first study drug dose, and then every 2 cycles (8 weeks) up to objective disease progression by RECIST, assessed up to 35 months ]

Locations (8)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia--
Research SitePalm SpringsCalifornia--
Research SiteAuroraColorado--
Research SiteNewarkDelaware--
Research SiteNew YorkNew York--
Research SitePhiladelphiaPennsylvania--
Research SiteNashvilleTennessee--
Research SiteSeattleWashington--

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