Clinical trial NCT01661868: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Keywords: BRCA1 mutation
BRCA2 mutation
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2012-08-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Response Rates
timeFrame: 1 year
Secondary outcomes:
measure: Toxicity
timeFrame: 1 year
measure: Progression free survival
timeFrame: 1 year
measure: Response Rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Ursula A Matulonis, MD
role: PRINCIPAL_INVESTIGATOR
References: