Brief Title
Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer
Official Title
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
Brief Summary
This research study is a way of gaining new knowledge about a drug called olaparib in women
who have either: 1)never received a PARP inhibitor before to treat ovarian cancer (group 1)
or 2)participants who have received a PARP inhibitor before to treat ovarian cancer, with the
exception of olaparib (group 2). PARP inhibitors are drugs tht prevent cancer cells from
repairing their DNA. In this research study, we are looking to see how well the drug olaparib
works in women who have never received a PARP inhibitor for recurrent ovarian cancer as well
as those who have received a prior PARP inhibitor and whose cancer has re-grown after
receiving that PARP inhibitor.
Detailed Description
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Response Rates
Secondary Outcome
Toxicity
Condition
Ovarian Cancer
Intervention
Olaparib
Study Arms / Comparison Groups
PARP Inhibitor Naive
Description: Patients with no prior PARP inhibitor treatment
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
August 2012
Completion Date
August 2012
Primary Completion Date
August 2012
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ursula A Matulonis, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01661868
Organization ID
11-170
Responsible Party
Principal Investigator
Study Sponsor
Dana-Farber Cancer Institute
Study Sponsor
Ursula A Matulonis, MD, Principal Investigator, Dana-Farber Cancer Institute
Verification Date
August 2012