Study on Olaparib Maintenance Therapy for Patients with BRCA Mutated Ovarian Cancer After Initial Platinum-Based Chemotherapy
Sponsor: AstraZeneca
ClinicalTrials ID:NCT01844986
This clinical trial is testing the effectiveness of Olaparib as a maintenance treatment for women with advanced ovarian cancer who have a BRCA mutation and have completed their first round of platinum-based chemotherapy.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to evaluate if Olaparib, a maintenance therapy, can help control ovarian cancer in women with BRCA mutations after they have completed their first line of platinum-based chemotherapy. The study is designed to see if Olaparib can help maintain the positive effects of the initial treatment and prevent the cancer from progressing.
Description
This is a Phase III study, which means it is in the later stages of testing. It is a randomized, double-blind, placebo-controlled trial conducted at multiple centers. The study focuses on women with advanced ovarian cancer who have a BRCA mutation and have completed their first round of platinum-based chemotherapy. The goal is to determine if Olaparib can help maintain the benefits of the initial chemotherapy and delay the progression of the cancer.
Eligibility Criteria
Inclusion Criteria
- Women with newly diagnosed advanced ovarian cancer (FIGO stage III-IV) with a BRCA mutation.
- Completed first line of platinum-based chemotherapy (e.g., carboplatin or cisplatin).
- Stage III patients must have had one attempt at optimal debulking surgery.
- Stage IV patients must have had a biopsy and/or debulking surgery.
- Must show a complete or partial response to chemotherapy with no signs of disease progression.
- Must be randomized within 8 weeks after the last dose of chemotherapy.
Exclusion Criteria
- BRCA mutations that are not harmful or are of uncertain significance.
- Early stage ovarian cancer (FIGO Stage I, IIA, IIB, or IIC).
- Stable or progressive disease after first line chemotherapy.
- More than one debulking surgery before joining the study.
- Previous treatment for earlier stage ovarian, fallopian tube, or primary peritoneal cancer.
- Previous chemotherapy for any abdominal or pelvic tumor, unless it was for localized breast cancer completed over three years ago.
- Synchronous primary endometrial cancer unless specific criteria are met.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Clearview Cancer Institute | Huntsville | Alabama | |
| Providence Cancer Center | Anchorage | Alaska | |
| St. Joseph's Hospital & Medical Center | Phoenix | Arizona | |
| Cedars-Sinai Medical Center | Los Angeles | California | |
| University of California, Los Angeles | Los Angeles | California | |
| Kaiser Permanente | Oakland | California | |
| Kaiser Permanente | Roseville | California | |
| Stanford Women's Cancer Center | Stanford | California | |
| Babak Edraki | Walnut Creek | California | |
| University of Colorado | Aurora | Colorado |
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