Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer

Part of paid clinical trials in Stanford, California.

Sponsor
AstraZeneca
Study ID
NCT01081951
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 125 Years
Healthy Volunteers
Not accepted

Interventions

  • olaparib — DRUG
    Tablets Oral BID
  • paclitaxel — DRUG
    175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle
  • carboplatin — DRUG
    AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle
  • paclitaxel — DRUG
    175mg/m2 iv for up to 6 cycles (18 weeks)
  • Drug: carboplatin — DRUG
    AUC4 iv for up to 6 cycles (18 weeks)

Study Details

To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.

Key Dates

Start date
Feb 4, 2010
Status verified
May 2026
Primary completion
Oct 10, 2011
Completion
Dec 31, 2026

Study Design

Enrollment
162 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
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.
  • Active Comparator: 2
    paclitaxel iv and carboplatin iv

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months) ]

Locations (8)

FacilityCityStateZIPSite coordinators
Research SiteStanfordCalifornia94305-
Research SiteWest HollywoodCalifornia90048-
Research SiteOrlandoFlorida32806-
Research SiteIndianapolisIndiana46202-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02215-
Research SiteNew YorkNew York10016-
Research SitePortlandOregon97227-1191-

Find similar trials in Stanford, CA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Research Site· Stanford, CAResearch Site· West Hollywood, CAResearch Site· Orlando, FLResearch Site· Indianapolis, INResearch Site· Boston, MAResearch Site· New York, NY

Related Studies