Clinical trial NCT03079687: Expanded Access Program for Olaparib Tablets as Maintenance Therapy in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
Official title: 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.
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
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.
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2017-03-14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: Research Site
state: California
city: Newport Beach
country: United States
facility: Research Site
state: California
city: Roseville
country: United States
facility: Research Site
state: California
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Scarborough
country: United States
facility: Research Site
state: Maine
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Rochester
country: United States
facility: Research Site
state: Minnesota
city: Columbia
country: United States
facility: Research Site
state: Missouri
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Portland
country: United States
facility: Research Site
state: Oregon
Study officials:
References: