Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
AstraZeneca
Study ID
NCT01844986
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Advanced Ovarian Cancer
  • BRCA Mutation
  • Complete Response
  • FIGO Stage III-IV
  • First Line Platinum Chemotherapy
  • Newly Diagnosed
  • Partial Response

Eligibility Criteria

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

Interventions

  • Olaparib 300mg tablets — DRUG
    Olaparib/placebo tablets p.o 300mg twice daily for up to 2 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.

Study Details

Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.

Key Dates

Start date
Aug 26, 2013
Status verified
Nov 2025
Primary completion
May 17, 2018
Completion
Aug 29, 2028

Study Design

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

Arms

  • Experimental: Olaparib tablets p.o. 300mg twice daily
    Olaparib/placebo tablets p.o 300mg twice daily for up to 3 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity
  • Placebo Comparator: Placebo tablets p.o. twice daily
    Olaparib/placebo tablets p.o 300mg twice daily for up to 3 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity

Primary Outcome Measure

Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) [ Time Frame: Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018 ]

Locations (81)

FacilityCityStateZIPSite coordinators
Clearview Cancer InstituteHuntsvilleAlabama--
Providence Cancer CenterAnchorageAlaska--
St. Joseph's Hospital & Medical CenterPhoenixArizona--
Cedars-Sinai Medical CenterLos AngelesCalifornia--
University of California, Los AngelesLos AngelesCalifornia--
Kaiser PermanenteOaklandCalifornia--
Kaiser PermanenteRosevilleCalifornia--
Stanford Women's Cancer CenterStanfordCalifornia--
Babak EdrakiWalnut CreekCalifornia--
University of ColoradoAuroraColorado--
Univ of Connecticut Health CenterFarmingtonConnecticut--
Smilow Cancer Hospital at Yale New HavenNew HavenConnecticut--
Florida Hospital Cancer InstituteOrlandoFlorida--
Gynecologic Cancer CenterOrlandoFlorida--
H Lee Moffitt Cancer Center and Research InstituteTampaFlorida--
Northside HospitalAtlantaGeorgia--
Northeast Georgia Medical CenterGainesvilleGeorgia--
Nancy N. & J.C. Lewis Cancer and Research PavillionSavannahGeorgia--
The Queen's Medical CenterHonoluluHawaii--
University of HawaiiHonoluluHawaii--
Northwestern UniversityChicagoIllinois--
Univ Chicago Medical CenterChicagoIllinois--
Advocate Lutheran General HospitalPark RidgeIllinois--
Indiana UniversityIndianapolisIndiana--
St. Vincent Hospital & Health Care CenterIndianapolisIndiana--
Northern Indiana Cancer Research ConsortiumMishawakaIndiana--
McFarland Clinic, P.C.AmesIowa--
Norton Cancer Institute ResearchLouisvilleKentucky--
Maine Medical PartnersScarboroughMaine--
Greater Baltimore Medical CenterBaltimoreMaryland--
Johns HopkinsBaltimoreMaryland--
Walter Reed National Military Medical CenterBethesdaMaryland--
Beth Israel Deaconess Medical CenterBostonMassachusetts--
Dana Farber Cancer InstituteBostonMassachusetts--
Massachusetts General HospitalBostonMassachusetts--
Henry Ford Health SystemDetroitMichigan--
Gynecologic Oncology of West MI, PLLCGrand RapidsMichigan--
Minnesota Oncology Hematology, PAEdinaMinnesota--
Mayo Clinic - Rochester, MNRochesterMinnesota--
University of Mississippi Medical CenterJacksonMississippi--
Washington University School of MedicineSt LouisMissouri--
Missouri Valley Cancer Consortium CCOPOmahaNebraska--
Nebraska Methodist HospitalOmahaNebraska--
Womens Cancer Center of NevadaLas VegasNevada--
MD Anderson at Cooper Cancer CenterCamdenNew Jersey--
John Theurer Cancer CenterHackensackNew Jersey--
University of New MexicoAlbuquerqueNew Mexico--
Women's Cancer Care AssociatesAlbanyNew York--
Roswell Park Cancer InstituteBuffaloNew York--
Memorial Sloan Kettering Cancer CenterNew YorkNew York--
Mount Sinai Medical Center - New YorkNew YorkNew York--
Perlmutter Cancer CenterNew YorkNew York--
Hope Women's Cancer CentersAshevilleNorth Carolina--
UNC Chapel HillChapel HillNorth Carolina--
Levine Cancer InstituteCharlotteNorth Carolina--
Duke University Medical CenterDurhamNorth Carolina--
Sanford Roger Maris Cancer CenterFargoNorth Dakota--
Aultman HospitalCantonOhio--
Cleveland Clinic Cancer Center at Fairview HospitalClevelandOhio--
Cleveland Clinic FoundationClevelandOhio--
University Hospital Case Medical CenterClevelandOhio--
Research SiteColumbusOhio43210-
Kettering Medical CenterKetteringOhio--
Hillcrest Hospital Cancer CenterMayfield HeightsOhio--
Peggy and Charles Stephenson Cancer CenterOklahoma CityOklahoma--
Abington Memorial HospitalAbingtonPennsylvania--
St. Luke's University Health NetworkBethlehemPennsylvania--
The University of PennsylvaniaPhiladelphiaPennsylvania--
Women and Infants HospitalProvidenceRhode Island--
South Carolina Oncology Associates, PAColumbiaSouth Carolina--
Avera Cancer InstituteSioux FallsSouth Dakota--
Sanford Clinic Women's HealthSioux FallsSouth Dakota--
University of Texas Southwestern Medical CenterDallasTexas--
MD Anderson Cancer CenterHoustonTexas--
University of Texas Health Science Center of HoustonHoustonTexas--
University of VirginiaCharlottesvilleVirginia--
Virginia Oncology AssociatesNorfolkVirginia--
Carilion Clinic Gynecological OncologyRoanokeVirginia--
Aurora Baycare Medical CenterGreen BayWisconsin--
University of Wisconsin-MadisonMadisonWisconsin--
Froedtert Memorial HospitalMilwaukeeWisconsin--

Find similar trials in Huntsville, AL

By research site
Clearview Cancer Institute· Huntsville, ALProvidence Cancer Center· Anchorage, AKSt. Joseph's Hospital & Medical Center· Phoenix, AZCedars-Sinai Medical Center· Los Angeles, CAUniversity of California, Los Angeles· Los Angeles, CAKaiser Permanente· Oakland, CA

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