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

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ClinicalTrials.gov Identifier: NCT03079687
Expanded Access Status : Approved for marketing
First Posted : March 14, 2017
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment
Ovarian Cancer Drug: Olaparib tablets

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.
Study Design
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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
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.

Resource links provided by the National Library of Medicine

Drug Information available for: Olaparib

Interventions
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Intervention Details:
  • Drug: Olaparib tablets
    Patients will receive olaparib tablets 300mg (two 150mg tablets) twice daily.
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079687


Locations
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United States, California
Research Site
Duarte, California, United States, 91010
Research Site
Newport Beach, California, United States, 92663
Research Site
Roseville, California, United States, 95661
United States, Florida
Research Site
Gainesville, Florida, United States, 32608
United States, Maine
Research Site
Scarborough, Maine, United States, 04074
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21201
United States, Minnesota
Research Site
Rochester, Minnesota, United States, 55905
United States, Missouri
Research Site
Columbia, Missouri, United States, 65212
United States, New Mexico
Research Site
Albuquerque, New Mexico, United States, 87106
United States, North Carolina
Research Site
Durham, North Carolina, United States, 27710
Research Site
Winston-Salem, North Carolina, United States, 27157-1023
United States, Ohio
Research Site
Cleveland, Ohio, United States, 44195
United States, Oregon
Research Site
Portland, Oregon, United States, 97239
Sponsors and Collaborators
AstraZeneca
Parexel
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03079687    
Other Study ID Numbers: D0816R00014
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Keywords provided by AstraZeneca:
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.
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
 Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents