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Expanded Access Program for Olaparib Tablets as Maintenance Therapy in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer.

NCT ID: NCT03079687

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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The Multiple Patient Expanded Access 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 who are in response (complete response or partial response) following platinum-based chemotherapy. The dose of olaparib tablets is 300 mg (two 150 mg tablets) taken twice daily, equivalent to a total daily dose of 600 mg. The 100 mg tablet is available for dose reduction. Treatment may continue until disease progression, unacceptable toxicity or withdrawal of patient consent. The program will collect observational data only.

Conditions

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Ovarian Cancer

Keywords

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Ovarian cancer gynaecological cancer platinum-sensitive disease platinum-sensitive relapsed Olaparib Ovarian Neoplasms Neoplasms Ovarian Disease fallopean tube cancer primary peritoneal cancer epithelial ovarian cancer PARP inhibitors Poly (ADP-ribose) polymerase inhibitors.

Interventions

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Olaparib tablets

Patients will receive olaparib tablets 300mg (two 150mg tablets) twice daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

For inclusion in the program patients must fulfill the following criteria:

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Parexel

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Duarte, California, United States

Site Status

Research Site

Newport Beach, California, United States

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Roseville, California, United States

Site Status

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Gainesville, Florida, United States

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Scarborough, Maine, United States

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Baltimore, Maryland, United States

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Rochester, Minnesota, United States

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Columbia, Missouri, United States

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Albuquerque, New Mexico, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Research Site

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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D0816R00014

Identifier Type: -

Identifier Source: org_study_id