Expanded Access Program for Olaparib Tablets as Maintenance Therapy in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
A Multiple Patient Expanded Access Program for Olaparib Tablets for the Maintenance Treatment Following Response (Complete Response or Partial Response) to Platinum-based Chemotherapy in Patients With Platinum-sensitive Relapsed High-grade Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
1 other identifier
expanded_access
N/A
1 country
13
Brief Summary
This is an open-label, single-arm, international, multicenter Multiple Patient Expanded Access Program (MPEAP). The program is designed to provide treatment access to olaparib tablets for patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer without other treatment options or eligible for an olaparib clinical trials.
Trial Health
Trial Health Score
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13 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2017
CompletedFirst Posted
Study publicly available on registry
March 14, 2017
CompletedOctober 25, 2017
October 1, 2017
March 8, 2017
October 23, 2017
Conditions
Keywords
Interventions
Patients will receive olaparib tablets 300mg (two 150mg tablets) twice daily.
Eligibility Criteria
You may qualify if:
- Provision of informed consent prior to any program specific procedures
- Female patients ≥ 18 years of age and has platinum-sensitive relapsed high grade epithelial ovarian, primary peritoneal or fallopian tube cancer
- Patient is in response (complete response or partial response) following platinum-based chemotherapy.
- Patients must have normal organ and bone marrow function measured within 28 days prior to administration of program treatment.
- Postmenopausal or evidence of non-childbearing status for women of childbearing potential.
You may not qualify if:
- Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
- Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors.
- Concomitant use of known strong or moderate CYP3A inducers. The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
- Patient with moderate or severe hepatic impairment.
- Breast feeding women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexelcollaborator
Study Sites (13)
Research Site
Duarte, California, 91010, United States
Research Site
Newport Beach, California, 92663, United States
Research Site
Roseville, California, 95661, United States
Research Site
Gainesville, Florida, 32608, United States
Research Site
Scarborough, Maine, 04074, United States
Research Site
Baltimore, Maryland, 21201, United States
Research Site
Rochester, Minnesota, 55905, United States
Research Site
Columbia, Missouri, 65212, United States
Research Site
Albuquerque, New Mexico, 87106, United States
Research Site
Durham, North Carolina, 27710, United States
Research Site
Winston-Salem, North Carolina, 27157-1023, United States
Research Site
Cleveland, Ohio, 44195, United States
Research Site
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2017
First Posted
March 14, 2017
Last Updated
October 25, 2017
Record last verified: 2017-10