Trial record 12 of 18 for:    parp inhibitor ovarian | Open Studies

Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AstraZeneca
Sponsor:
Collaborators:
European Network of Gynecological Oncology Trial Groups (ENGOT)
Myriad Genetics - BRAC Analysis test for FDA Premarket Approval (PMA)
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01874353
First received: June 7, 2013
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

Comparison of olaparib against a placebo in patients with ovarian cancer whose cancer has already improved by taking platinum based chemotherapy. The patients must also have a fault in their DNA which codes for the BRCA protein. The BRCA protein helps mend broken DNA in the cells of the body; if this protein doesn't work properly it can increase the chance of getting cancer. The aim of this study is to see whether patients taking olaparib tablets last longer until their cancer gets worse, compared to those taking the placebo tablet. The study is also looking to see if there is an overall improvement to how long the patients survive whilst taking olaparib tablets compared to the placebo tablets; and the quality of their life whilst living with ovarian cancer.


Condition Intervention Phase
Platinum Sensitive
BRCA Mutated
Relapsed Ovarian Cancer
Following Complete or Partial Response to Platinum Based Chemotherapy
Drug: Olaparib 300mg tablets
Drug: Placebo to match olaparib 300mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Randomised, Double Blind, Placebo Controlled Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients With a Complete or Partial Response Following Platinum Based Chemotherapy

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Progression Free Survival (PFS) by central review of RECIST data. [ Time Frame: Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Study data collection expected to last until 2018. ] [ Designated as safety issue: No ]
    To determine the efficacy by progression free survival (using blinded independent central review) according to modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1) of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.


Secondary Outcome Measures:
  • Efficacy in patients following platinum based chemotherapy by assessment of overall survival [ Time Frame: Survival assessed every 4 weeks until treatment discontinues, then assessed every 12 weeks. Study data collection expected to last until 2018. ] [ Designated as safety issue: No ]
    To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of overall survival (OS).

  • Efficacy in patients following platinum based chemotherapy by assessment of time to earliest progression by RECIST or Cancer Antigen (CA-125) or death [ Time Frame: CA-125 performed at baseline then every 4 weeks. Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks until objective radiological disease progression. Study data collection expected to last until 2018. ] [ Designated as safety issue: No ]
    To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of time to earliest progression by RECIST or CA-125 or death.

  • Efficacy in patients following platinum based chemotherapy by assessment of time from randomisation to second progression [ Time Frame: Radiologic scans performed at baseline then every 12 weeks for 72 weeks, then every 24 weeks thereafter until first progression. Disease then assessed per local practice until second progression. Study data collection expected to last until 2018 ] [ Designated as safety issue: No ]
    To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation up to second progression

  • Time to deterioration of Health-Related Quality of Life (HRQoL) as assessed by TOI and FACT-O [ Time Frame: Paper questionnaires completed by patient at baseline, at Day 29 and then in line with RECIST assessments, until disease progression. Study data collection expected to last until 2018. ] [ Designated as safety issue: No ]
    To compare the effects of olaparib maintenance monotherapy compared to placebo on the rate of deterioration of Health-related Quality of Life (HRQoL) as assessed by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.

  • Efficacy in patients with a deleterious or suspected deleterious variant in either of the BRCA genes by assessment of PFS. [ Time Frame: Radiologic scans performed at baseline then every ~12 weeks for the first 72 weeks, then every ~24 weeks thereafter, assessed until disease progression. Study data collection expected to last until 2018. ] [ Designated as safety issue: No ]
    To assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).

  • To determine the exposure to olaparib by Pharmacokinetic analysis [ Time Frame: Pharmacokinetics sampling to be performed in a subset of patients. Sampling times: Day 1 pre-dose & 1 hour; Day 15 pre-dose & 1 hour; Day 29 pre-dose, 0.5-1 hour, 1-3 hours 3-6 hours and 6-12 hours. ] [ Designated as safety issue: No ]
    To determine the exposure to olaparib in patients receiving olaparib maintenance monotherapy

  • Safety and tolerability of olaparib by assessment of the number of AEs. [ Time Frame: AEs collected from informed consent until post treatment 30-day follow-up period. Study data collection expected to last until 2018. ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of olaparib maintenance monotherapy in BRCA mutated relapsed ovarian cancer patients.

  • Safety and tolerability of olaparib by review of laboratory parameters, ECG and vital signs [ Time Frame: ssessments until study treatment discontinuation. Study data collection expected to last until 2018. ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of olaparib maintenance monotherapy in BRCA mutated relapsed ovarian cancer patients.

  • Efficacy of olaparib by time to first subsequent therapy or death (TFST). [ Time Frame: Time elapsed from randomisation to first subsequent therapy or death. Assessed at time of primary PFS analysis and at final OS analysis. Study data collection expected to last ~7 years. ] [ Designated as safety issue: No ]
    To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to first subsequent therapy or death (TFST).

  • Efficacy of olaparib by time to second subsequent therapy or death (TSST). [ Time Frame: Time elapsed from randomisation to second subsequent therapy or death. Assessed at time of primary PFS analysis and at final OS analysis. Study data collection expected to last ~7 years. ] [ Designated as safety issue: No ]
    To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to second subsequent therapy or death (TSST).

  • Efficacy of olaparib by time from randomisation to study treatment discontinuation or death (TDT). [ Time Frame: Time elapsed from randomisation to study treatment discontinuation or death. Assessed at time of primary PFS analysis and at final OS analysis. Study data collection expected to last ~7 years. ] [ Designated as safety issue: No ]
    To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to study treatment discontinuation or death (TDT).


Estimated Enrollment: 440
Study Start Date: September 2013
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olaparib 300mg tablets
Taken orally twice daily
Drug: Olaparib 300mg tablets
300mg Olaparib or placebo tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.
Placebo Comparator: Placebo tablets
Taken orally twice daily
Drug: Placebo to match olaparib 300mg
300mg Olaparib or placebo tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.

Detailed Description:

A Phase III, randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy of olaparib maintenance monotherapy in relapsed high grade serous ovarian cancer (HGSOC) patients (including patients with primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer with BRCA mutations (documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)) who have responded following platinum based chemotherapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be ≥ 18 years of age.

    • Female patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer.
    • Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
    • Patients who have received at least 2 previous lines of platinum containing therapy prior to randomisation

For the penultimate chemotherapy course prior to enrolment on the study:

• Patient defined as platinum sensitive after this treatment; defined as disease progression greater than 6 months after completion of their last dose of platinum chemotherapy

For the last chemotherapy course immediately prior to randomisation on the study:

  • Patients must be, in the opinion of the investigator, in response (partial or complete radiological response), or may have no evidence of disease (if optimal cytoreductive surgery was conducted prior to chemotherapy), and no evidence of a rising CA-125, following completion of this chemotherapy course
  • Patient must have received a platinum based chemotherapy regimen (e.g. carboplatin or cisplatin) and have received at least 4 cycles of treatment
  • Patients must be randomized within 8 weeks of their last dose of chemotherapy

Exclusion Criteria:

  • Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  • BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental (e.g., "Variants of uncertain clinical significance" or "Variant of unknown significance" or "Variant, favor polymorphism" or "benign polymorphism" etc.)
  • Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874353

Contacts
Contact: Elizabeth Lowe ClinicalTrialTransparency@astrazeneca.com
Contact: AstraZeneca Cancer Study Locator Service http://www.emergingmed.com/networks/AstraZeneca 001-877-400-4656 astrazeneca@emergingmed.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States
United States, California
Cedars-Sinai Medical Center Withdrawn
Los Angeles, California, United States
Palo Alto Foundation Medical Group Recruiting
San Fransisco, California, United States
Stanford Univ Med Center Withdrawn
Stanford, California, United States
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States
United States, Connecticut
The Hospital of Central Connecticut Recruiting
New Britain, Connecticut, United States
Smilow Cancer Hospital at Yale New Haven Withdrawn
New Haven, Connecticut, United States
United States, Florida
Salom and Tangir LLC Recruiting
Miramar, Florida, United States
Gynecologic Cancer Center Recruiting
Orlando, Florida, United States
United States, Illinois
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States
North Shore University Not yet recruiting
Evanston, Illinois, United States
United States, Maryland
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States
Johns Hopkins Not yet recruiting
Baltimore, Maryland, United States
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center Withdrawn
Boston, Massachusetts, United States
United States, New Jersey
MD Anderson at Cooper Cancer Center Recruiting
Camden, New Jersey, United States
MD Anderson at Cooper Cancer Center Recruiting
Voorhees, New Jersey, United States
United States, New York
Womens Cancer Care Associates Recruiting
Albany, New York, United States
Winthrop Gynecologic Oncology Associates Recruiting
Mineola, New York, United States
Perlmutter Cancer Center Withdrawn
New York, New York, United States
United States, Ohio
OSU JamesCare at Mill Run Recruiting
Hillard, Ohio, United States
United States, Pennsylvania
Abington Memorial Hospital Withdrawn
Abington, Pennsylvania, United States
United States, Tennessee
Henry Joyce Cancer Clinic Not yet recruiting
Nashville, Tennessee, United States
United States, Texas
University of Texas Recruiting
Houston, Texas, United States
United States, Wisconsin
Aurora St Lukes Medical Center Recruiting
Milwaukee, Wisconsin, United States
Australia
Mercy Hospital for Women Recruiting
Heidelberg, Australia
The Royal Womens Hospital Recruiting
Parkville, Australia
Prince of Wales Hospital Recruiting
Randwick, Australia
Belgium
UCL Saint-Luc Recruiting
Brussels (Wuluw-St-Lambert), Belgium
U.Z. Gent Recruiting
Gent, Belgium
UZ Leuven Gasthuisberg Recruiting
Leuven, Belgium
Brazil
Centro Diagnóstico Barretos Not yet recruiting
Barretos, Brazil
Centro Regional Integrado de Oncologia Not yet recruiting
Fortaleza, Brazil
Hospital Araujo Jorge Not yet recruiting
Goiânia, Brazil
Hospital de Caridade de Ijuí Not yet recruiting
Ijuí, Brazil
Centro de Novos Tratamentos Itajai Not yet recruiting
Itajai, Brazil
Hospital da Cidade de Passo Fundo Not yet recruiting
Passo Fundo, Brazil
Hospital de Clinicas de Porto Alegre Not yet recruiting
Porto Alegre, Brazil
Hospital Sao Lucas da PUC de Porto Alegre Not yet recruiting
Porto Alegre, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alagre Not yet recruiting
Porto Alegre, Brazil
Instituto Nacional do Cancer Not yet recruiting
Rio de Janeiro, Brazil
Hospital de Base São José do Rio Preto Not yet recruiting
São José do Rio Preto, Brazil
Instituto do Câncer de São Paulo Not yet recruiting
São Paulo, Brazil
Centro de Referencia da Saude da Mulher Not yet recruiting
São Paulo, Brazil
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada
London Health Sciences Centre Recruiting
London, Ontario, Canada
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada
Sunnybrook Health Sciences Center Recruiting
Toronto, Ontario, Canada
Canada, Quebec
CHUM - Hopital Norte-Dame Recruiting
Montreal, Quebec, Canada
CHUS Site Fleurimont Recruiting
Sherbrooke, Quebec, Canada
Canada
Hotel-Dieu de Quebec Recruiting
Quebec, Canada
France
Institut Bergonie Recruiting
Bordeaux, France
CAC François Baclesse Recruiting
Caen Cedex, France
69LYON, C Bérard, Onco Recruiting
Lyon Cedex 08, France
Centre Catherine de Sienne Recruiting
Nantes,, France
Hopital Européen Georges Pompidou Recruiting
Paris, France
75PARIS, H Tenon, Onco Recruiting
Paris, France
Institut Curie Paris Et Saint Cloud Recruiting
Paris Cedex 5, France
69PIERREBE, CH Lyon Sud, Recruiting
Pierre Benite Cedex, France
92STCLOUD, C Huguenin, Onco Recruiting
Saint Cloud, France
Institut Claudius Regaud Recruiting
Toulouse, France
Centre Alexis Vautrin Recruiting
Vandoeuvre Les Nancy, France
Institut Gustave Roussy Recruiting
Villejuif Cedex, France
Germany
Helios-Kliniken Berlin - Buch Not yet recruiting
Berlin, Germany
Friedrich-Alexander-Universität Erlangen-Nürnberg Recruiting
Erlangen, Germany
Klinikum Essen-Mitte,Evang. Huyssens-Stiftung/Knapps gGmbH Recruiting
Essen, Germany
Johann-Wolfgang Goethe-Universität Recruiting
Frankfurt, Germany
Medizinische Hochschule Hannover Recruiting
Hannover, Germany
Klinikum der Universität zu Köln Recruiting
Köln, Germany
Universitätsklinikum Schleswig-Holstein Recruiting
Lübeck, Germany
Universitätsklinik Gießen und Marburg GmbH Recruiting
Marburg, Germany
Klinikum rechts der Isar der Technischen Universität Recruiting
München, Germany
Onkologie Ravensburg Recruiting
Ravensburg, Germany
Universitätsklinikum Rostock Recruiting
Rostock, Germany
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel
Sapir Medical Centre Recruiting
Kfar Saba, Israel
Tel Hashomer Recruiting
Ramat Gan, Israel
Italy
Ospedali Galliera Recruiting
Genova, Italy
Istituto Europeo di Oncologia Recruiting
Milano, Italy
Azienda Ospedaliera Policlinico Di Modena Recruiting
Modena, Italy
Istituto Nazionale Tumori Fondazione Pascale Recruiting
Napoli, Italy
Istituto Oncologico Veneto Irccs Recruiting
Padova, Italy
Policlinico Universitario A. Gemelli Recruiting
Roma, Italy
Istituto Regina Elena-Polo Oncologico Ifo Recruiting
Roma, Italy
Japan
Hyogo Cancer Center Recruiting
Akashi-shi, Japan
National Cancer Center Hospital Recruiting
Chuo-ku, Japan
National Hospital Organization Kyushu Cancer Center Recruiting
Fukuoka, Japan
Saitama Medical University International Medical Center Recruiting
Hidaka-shi, Japan
National Hospital Organisation Shikoku Cancer Center Recruiting
Matsuyama-shi, Japan
Niigata University Medical and Dental Hospital Recruiting
Niigata-shi, Japan
Kinki University Hospital Recruiting
Osakasayama-shi, Japan
Hokkaido University Recruiting
Sapporo-shi, Japan
Korea, Republic of
Gangnam Severance Hospital Not yet recruiting
Seoul, Korea, Republic of
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of
Netherlands
Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital Recruiting
Amsterdam, Netherlands
Maastricht Universitair Medisch Centrum Recruiting
Maastricht, Netherlands
Universitair Medisch Centrum St. Radboud Recruiting
Nijmegen, Netherlands
Erasmus Medisch Centrum Recruiting
Rotterdam, Netherlands
Poland
Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna Recruiting
Grzepnica, Poland
SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii Recruiting
Olsztyn, Poland
Wojewódzki Szpital Specjalistyczny w Olsztynie Recruiting
Olsztyn, Poland
Szpital Specjalistyczny im. Swietej Rodziny SPZOZ Recruiting
Warszawa, Poland
Centrum Onkologii Instytut im Marii Sklodowskiej-Curie Recruiting
Warszawa, Poland
Russian Federation
Chemotherapy Department, Russian Cancer Research Centre Recruiting
Moscow, Russian Federation
St.Petersburg City Oncology Dispensary, Dept. Gynecology Recruiting
Saint Petersburg, Russian Federation
Cancer Research Institute Recruiting
Saint Petersburg, Russian Federation
Leningrad Regional Oncology Dispensary Recruiting
St.Petersburg, Russian Federation
Spain
Barcelona,H.de la Sta.Creu i S.Pau,Oncología Recruiting
Barcelona, Spain
Barcelona,H.Clinic i Provincial,Oncología Recruiting
Barcelona, Spain
Córdoba,H.Reina Sofía,Oncología Recruiting
Córdoba, Spain
Gerona,H.Josep Trueta,Oncología Recruiting
Gerona, Spain
Madrid,H.12 de Octubre,Oncología Recruiting
Madrid, Spain
Madrid, H.C.S.Carlos,Oncología Recruiting
Madrid, Spain
Oviedo,H.Cent.Asturias,Onco Recruiting
Oviedo, Spain
Hospital Provincial de Navarra Recruiting
Pamplona, Spain
Valencia,H.C.U.Valencia,Oncología Recruiting
Valencia, Spain
Valencia, IVO, Oncología Recruiting
Valencia, Spain
United Kingdom
City Hospital Birmingham Cancer Trials Team Recruiting
Birmingham, United Kingdom
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom
Arden Cancer Centre Recruiting
Coventry, United Kingdom
Edinburgh Cancer Research UK Centre Recruiting
Edinburgh, United Kingdom
Royal Marsden Hospital Recruiting
London, United Kingdom
Cancer Research UK and UCL Cancer Trials Centre Recruiting
London, United Kingdom
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom
Royal Marsden Hospital and Institute of Cancer Research Recruiting
Sutton, United Kingdom
Sponsors and Collaborators
AstraZeneca
European Network of Gynecological Oncology Trial Groups (ENGOT)
Myriad Genetics - BRAC Analysis test for FDA Premarket Approval (PMA)
Investigators
Principal Investigator: Professor E Pujade-Lauraine, MD, PhD Universite de Paris Descartes, France
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01874353     History of Changes
Other Study ID Numbers: D0816C00002
Study First Received: June 7, 2013
Last Updated: July 30, 2014
Health Authority: Australia: National Health and Medical Research Council
Brazil: National Health Surveillance Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
China: National Natural Science Foundation
Canada: Canadian Institutes of Health Research
Israel: Israeli Health Ministry Pharmaceutical Administration
Japan: Pharmaceuticals and Medical Devices Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Russia: FSI Scientific Center of Expertise of Medical Application
Spain: Spanish Agency of Medicines

Keywords provided by AstraZeneca:
BRCA
Ovarian cancer
Chemotherapy
PARP Inhibitor
Platinum sensitive

Additional relevant MeSH terms:
Ovarian Neoplasms
Ovarian Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 31, 2014