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Clinical Trial VICCGYN1439

Title

A Phase III Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients who are in Complete or Partial Response Following Platinum based Chemotherapy

Principal Investigator(s)

Marta Crispens

Details

  • Protocol No. VICCGYN1439
  • Open Date: 07/23/2014
  • Staging: Phase III
  • Age Group: Adults
  • Scope: National
  • Objective: To determine the efficacy by progression free survival (using blinded independent central review according to modified RECIST v1.1) 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.
  • Disease Sites: Ovarian
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Olaparib
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01874353
  • Secondary Protocol No: D0816C00002

Description

Participants are being asked to take part in this research study because participants have been diagnosed with ovarian cancer, primary peritoneal cancer (the lining of the inside of the abdomen) and / or fallopian-tube cancer. To participate in this study participants will be tested for a specific type of genetic mutation in the BRCA genes. A mutation is a change in the participants deoxyribonucleic acid (DNA), which affects how some processes in the body work. Participants had an improvement in the cancer (response) following platinum based chemotherapy. The current medical practice in the participants situation is not to take further medications until the cancer comes back. This study is being carried out to test whether a new treatment, called olaparib, is effective in treating the participants ovarian cancer, and preventing the cancer from coming back as quickly as it could if the participants didn-t take further medications.

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.