Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
Condition(s) studied
Investigational drug(s) / intervention(s)
Olaparib 300mg tablets: Olaparib/placebo tablets p.o 300mg twice daily for up to 2 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.
Study summary
Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) — Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018
To determine the efficacy by progression free survival (PFS) using investigator assessment according to modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy.
Trial sites (177)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | |
| Univ of Connecticut Health Center | Farmington | Connecticut | |
| Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut | |
| Florida Hospital Cancer Institute | Orlando | Florida | |
| Gynecologic Cancer Center | Orlando | Florida | |
| H Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | |
| Northside Hospital | Atlanta | Georgia | |
| Northeast Georgia Medical Center | Gainesville | Georgia | |
| Nancy N. & J.C. Lewis Cancer and Research Pavillion | Savannah | Georgia | |
| The Queen's Medical Center | Honolulu | Hawaii | |
| University of Hawaii | Honolulu | Hawaii | |
| Northwestern University | Chicago | Illinois | |
| Univ Chicago Medical Center | Chicago | Illinois | |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | |
| Indiana University | Indianapolis | Indiana | |
| St. Vincent Hospital & Health Care Center | Indianapolis | Indiana | |
| Northern Indiana Cancer Research Consortium | Mishawaka | Indiana | |
| McFarland Clinic, P.C. | Ames | Iowa | |
| Norton Cancer Institute Research | Louisville | Kentucky | |
| Maine Medical Partners | Scarborough | Maine | |
| Greater Baltimore Medical Center | Baltimore | Maryland | |
| Johns Hopkins | Baltimore | Maryland | |
| Walter Reed National Military Medical Center | Bethesda | Maryland | |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Henry Ford Health System | Detroit | Michigan | |
| Gynecologic Oncology of West MI, PLLC | Grand Rapids | Michigan | |
| Minnesota Oncology Hematology, PA | Edina | Minnesota | |
| Mayo Clinic - Rochester, MN | Rochester | Minnesota | |
| University of Mississippi Medical Center | Jackson | Mississippi |
+ 137 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT01844986 on ClinicalTrials.gov ↗ ← All trials in France