Study on Olaparib Treatment for Ovarian Cancer Patients with BRCA Mutations After Responding to Platinum Chemotherapy
Sponsor: AstraZeneca
ClinicalTrials ID:NCT01874353
This clinical trial is testing whether the drug olaparib can help delay the worsening of ovarian cancer in patients with BRCA mutations who have already responded to platinum-based chemotherapy.
Patient Parameters
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Program Overview
The study aims to find out if taking olaparib tablets can help patients with high-grade serous ovarian cancer or high-grade endometrioid cancer, who have BRCA mutations, to live longer without their cancer getting worse after responding to platinum-based chemotherapy. It also looks at whether olaparib improves overall survival and quality of life compared to a placebo.
Description
This study compares the effects of olaparib tablets to a placebo in patients with ovarian cancer who have shown improvement after platinum-based chemotherapy. These patients have a specific genetic fault in the BRCA gene, which normally helps repair damaged DNA. When this gene doesn't work properly, it can increase cancer risk. The study's goal is to see if olaparib can help patients live longer without their cancer worsening, improve overall survival, and enhance quality of life compared to those taking a placebo.
Eligibility Criteria
Inclusion Criteria
- Women aged 18 or older.
- Diagnosed with relapsed high-grade serous ovarian cancer, including primary peritoneal or fallopian tube cancer, or high-grade endometrioid cancer.
- Have a harmful mutation in the BRCA1 or BRCA2 gene.
- Have received at least two previous courses of platinum-based chemotherapy.
- Cancer must have responded to the last chemotherapy, with no signs of worsening for more than 6 months after the last platinum treatment.
- Must be in partial or complete response, or have no evidence of disease after the last chemotherapy.
- Must have received at least four cycles of platinum-based chemotherapy.
- Must start the study within 8 weeks of the last chemotherapy dose.
- Maintenance treatment after the second-to-last platinum regimen is allowed.
Exclusion Criteria
- Involvement in planning or conducting the study.
- BRCA mutations that are not harmful or are of uncertain significance.
- Patients who had fluid drained from their abdomen during the last two cycles of chemotherapy before joining the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | |
| Palo Alto Foundation Medical Group | San Francisco | California | |
| University of Colorado | Aurora | Colorado | |
| The Hospital of Central Connecticut | New Britain | Connecticut | |
| Gynecologic Cancer Center | Orlando | Florida | |
| North Shore University | Evanston | Illinois | |
| Greater Baltimore Medical Center | Baltimore | Maryland | |
| Johns Hopkins | Baltimore | Maryland | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| Massachusetts General Hospital | Boston | Massachusetts |
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