Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer	Drug: Olaparib	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

Response Rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Assess toxicity profile of olaparib according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4)
Progression free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Assess progression free survival (PFS) and 6 month PFS rate
Response Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Assess CA125 response rate

Enrollment:	0
Study Start Date:	August 2012
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: PARP Inhibitor Naive Patients with no prior PARP inhibitor treatment	Drug: Olaparib Tablet formulation will be used. Other Name: AZD2281
Active Comparator: Prior PARP Inhibitor Patients previously treated with a PARP inhibitor other than olaparib	Drug: Olaparib Tablet formulation will be used. Other Name: AZD2281

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01661868

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Dana-Farber Cancer Institute

Investigators

Principal Investigator:

Ursula A Matulonis, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Ursula A. Matulonis, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT01661868 History of Changes
Other Study ID Numbers:	11-170
Study First Received:	October 24, 2011
Last Updated:	August 18, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

BRCA1 mutation
BRCA2 mutation

Additional relevant MeSH terms:

Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female

Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on May 19, 2013