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

Study Overview
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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.

Official Title
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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.

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Olaparib tablets


Participation Criteria
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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 should not enter the program if any of the following exclusion criteria are fulfilled: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Olaparib tablets|Patients will receive olaparib tablets 300mg (two 150mg tablets) twice daily.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary peritoneal cancer, Ovarian cancer, gynaecological cancer, platinum-sensitive disease, platinum-sensitive relapsed, Olaparib, Ovarian Neoplasms, Neoplasms, Ovarian Disease, fallopean tube cancer, epithelial ovarian cancer, PARP inhibitors, Poly (ADP-ribose) polymerase inhibitors.