Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01661868
Recruitment Status : Withdrawn (Drug not available.)
First Posted : August 10, 2012
Last Update Posted : August 21, 2012
Information provided by (Responsible Party):
Ursula A. Matulonis, MD, Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer Drug: Olaparib Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Olaparib

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Response Rates [ Time Frame: 1 year ]
    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 :
  1. Toxicity [ Time Frame: 1 year ]
    Assess toxicity profile of olaparib according to the Common Terminology Criteria for Adverse Events (CTCAE, version 4)

  2. Progression free survival [ Time Frame: 1 year ]
    Assess progression free survival (PFS) and 6 month PFS rate

  3. Response Rate [ Time Frame: 1 year ]
    Assess CA125 response rate

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01661868

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Principal Investigator: Ursula A Matulonis, MD Dana-Farber Cancer Institute

Responsible Party: Ursula A. Matulonis, MD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT01661868     History of Changes
Other Study ID Numbers: 11-170
First Posted: August 10, 2012    Key Record Dates
Last Update Posted: August 21, 2012
Last Verified: August 2012

Keywords provided by Ursula A. Matulonis, MD, Dana-Farber Cancer Institute:
BRCA1 mutation
BRCA2 mutation

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents