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NCT01874353

A Phase

Note: This study is also known as the SOLO2 Studysolo2 logo

Study identifier: NCT01874353
Full study details on clinicaltrials.gov

Name of PARP Inhibitor used in study:

Olaparib (AstraZeneca)

Eligibility:

Inclusion Criteria

  • 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
    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.

Type of study:

Randomized Phase III

Treatment:

  • Patients will be randomized to one of two arms:
    • Olaparib 300 mg oral capsules twice daily
    • Placebo

Study sites:

To get more information about the study sites recruiting patients, contact:

Elizabeth Lowe: ClinicalTrialTransparency@astrazeneca.com

Florida

Orlando

Massachusetts
Boston

New York
Albany


International Sites

Australia
Parkville

Randwick

Canada
Ontario

Hamilton, Ontario

London, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Sherbrooke, Quebec, Canada

France
Bordeaux

Caen Cedex

Nantes

Paris

Paris Cedex 5

Pierre Benite Cedex

Saint Cloud

Toulouse

Vandoeuvre Les Nancy

Villejuif Cedex

Germany
Erlangen

Essen

Hannover

Köln

Lübeck

Marburg

München

Ravensburg, Germany

Israel
Haifa

Kfar Saba

Ramat Gan

Italy
Milano

Napoli

Padova

Roma

Japan
Chuo-ku

Fukuoka

Hidaka-shi

Niigata-shi

Netherlands
Amsterdam

Maastricht

Nijmegen

Rotterdam

Poland
Grzepnica

Olsztyn

Warszawa

Russian Federation
Saint Petersburg

Spain
Barcelona

Córdoba

Gerona

Madrid

Valencia

United Kingdom
Birmingham

Edinburgh

London

Manchester

Sutton

Page updated 03/05/14


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