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Phase II Study of Single Agent Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer With No Prior PARP Exposure or Prior PARP Inhibitor Exposure

Phase 2
18 Years
Not Enrolling
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

Thank you

Trial Information

Phase II Study of Single Agent Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer With No Prior PARP Exposure or Prior PARP Inhibitor Exposure

Olaparib tablets will be taken twice daily, orally, in treatment cycles lasting 4 weeks.

On days 1, 8, 12 and 22 of the first 2 cycles and day 1 of all other cycles, subjects will
have a physical exam, be asked questions about their general health, and specific questions
about any problems they might be having and any medications they are taking.

Tumor will be assess by either CT or MRI scan every 2 cycles (every 2 months). Tumor
biopsies will be optional in this study. Only participants that have received a PARP
inhibitor in the past will be asked to have a biopsy of their tumor.

Inclusion Criteria:

- Histologically confirmed ovarian, peritoneal or fallopian tube cancer that has
recurred following a platinum-based regimen used at initial diagnosis

- Measurable disease

- Estimated life expectancy greater than 16 weeks

- Normal organ and marrow function

- Evidence of non-childbearing status for women of childbearing potential

- Able to swallow oral medication

Exclusion Criteria:

- Pregnant or breastfeeding

- Prior PARP inhibitor use for another cancer such as breast cancer

- Receiving any other study agents or any other anti-cancer treatment

- Known brain metastases

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to olaparib

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive hear failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- History of a different malignancy unless disease-free for at least 5 years

- Currently experiencing seizures or currently being treated with any anti-epileptic
for seizures

- Human immunodeficiency virus (HIV) positive on combination antiretroviral therapy

- Presence of gastrointestinal disorders that, in the investigator's opinion, are
likely to interfere with the absorption of olaparib, or with the patient's ability to
take regular oral medication

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rates

Outcome Description:

To determine the RECIST 1.1. response rates of the oral PARP inhibitor olaparib based on prior exposure of a PARP inhibitor; patients who have received and subsequently have had disease progression with a prior PARP inhibitor versus no prior exposure to a PARP inhibitor in patients with germline BRCA mutations who have recurrent ovarian, fallopian tube or peritoneal cancer who have measurable cancer.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Ursula A Matulonis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

August 2012

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cancer
  • Fallopian Tube Cancer
  • BRCA1 mutation
  • BRCA2 mutation
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115