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Research & Clinical Trials > Study Search Tool > Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status

Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status

This study is open to:

Women with relapsed high-grade serous ovarian cancer can participate if they:

  • have at least 1 lesion that can be accurately measured at baseline by computed tomography (CT)/magnetic resonance imaging (MRI) and is suitable for repeated assessment;
  • have received at least 2 prior platinum-based lines of chemotherapy for ovarian cancer. Note: There is no limit on the number of non-platinum-based lines of chemotherapy;
  • are at least partially-platinum-sensitive (defined as progression 6 to 12 months after the end of the last platinum-based chemotherapy) or platinum sensitive 
  • have formalin fixed, paraffin embedded tumor sample (either archival or fresh sample) from the primary or recurrent cancer must be available for central testing. 
This study is not open to:

Participants are excluded if they:

  • have exposure to any investigational product within 30 days before the start of study
  • have any previous treatment with a PARP inhibitor, including olaparib
  • have platinum-resistant or refractory disease defined as progression during or within 6 months of the last platinum-based chemotherapy;
  • other cancer diagnosis within the last 5 years (few exceptions apply);
  • received any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment;
  • have had major surgery within 2 weeks of starting study treatment, and subjects must have recovered from any effects of any major surgery
Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status

Olaparib for Platinum Sensitive Relapsed Ovarian Cancer

Clinicaltrials.gov identifier:
NCT02983799

Treatment:
Ovarian

Study Contact Information

For information about the study, contact the AstraZeneca Clinical Study Information Center by phone: 1-877-240-9479 or by email.

About the Study

This study will look at olaparib (Lynparza) tablets as a treatment for relapsed ovarian cancer in women with, or without a BRCA mutation. Patients should have received at least 2 prior lines of platinum-based chemotherapy. All  participants will receive the study agent, olaparib. 

The study goal is to compare response to treatment based on whether women have an inherited BRCA mutation or BRCA-like cancer based on tumor tests.

Visit the study listing on clinicaltrials.gov for more information.

Type of Study

This is a nonrandomized, open label study. All  participants will receive the study agent, olaparib. This study is comparing response to treatment in four different grousp of patients. The study is non-randomized, meaning that patients will be assigned to one of four groups based on specifics of their cancer. All patients in the study will receive olaparib.

What the Study Entails

All patients enrolled in the study will receive the study agent, olaparib. Patients will take olaparib pills twice daily while on the study. 

Study Background

Olaparib belongs to a category of drugs known as PARP inhibitors. These agents have shown benefit for treating ovarian cancer in women with inherited BRCA mutations. The drugs also show benefit for patients who do not have a BRCA mutation. The study goal is to compare response to treatment in four different groups of ovarian cancer patients to see which patients benefit most from this drug.

  • Women with an inherited BRCA mutation
  • Women who are negative for an inherited BRCA mutation but have BRCA mutations in their tumor
  • Women who are negative for an inherited BRCA mutation but have an HRD positive tumor test 
  • Women who are negative for an inherited BRCA mutation and have an HRD negative tumor test

Study Sites

The study is open in many locations in the US. For all sites, contact the AstraZeneca Clinical Study Information Center by phone at: 1-877-240-9479 or by email. 

  • Alaska, Anchorage
  • California, Los Angeles
  • Maryland, Silver Spring
  • Massachusetts, Springfield
  • Michigan, Detroit
  • Minnesota, Minneapolis
  • Nebraska, Lincoln
  • New Jersey, Hackensack
  • New Jersey, Teaneck
  • Ohio, Cincinnati
  • Oregon, Portland
  • Pennsylvania, Philadelphia
  • Rhode Island, Providence
  • Texas, Dalls: Mary Crowley Cancer Research or call: 972-566-3000
  • Virginia, Annandale

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