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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.

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT03079687
Enrollment
Unknown
Registered
2017-03-14
Start date
Unknown
Completion date
Unknown
Last updated
2017-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

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.

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.

Detailed description

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.

Interventions

DRUGOlaparib tablets

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

Sponsors

Parexel
CollaboratorINDUSTRY
AstraZeneca
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026