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Clinical Trials in the UK / NCT01844986
Active, not recruiting Phase 3

Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.

NCT01844986 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2013-08-26
Last updated
2025-12-10

Condition(s) studied

Newly DiagnosedAdvanced Ovarian CancerFIGO Stage III-IVBRCA MutationComplete ResponsePartial ResponseFirst Line Platinum Chemotherapy

Investigational drug(s) / intervention(s)

Olaparib 300mg tablets

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

Sex
FEMALE
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria: * Female patients with newly diagnosed, histologically confirmed, high risk advanced (FIGO stage III - IV) BRCA mutated high grade serous or high grade endometrioid ovarian cancer, primary peritoneal cancer and / or fallopian - tube cancer who have completed first line platinum based chemotherapy (intravenous or intraperitoneal). * Stage III patients must have had one attempt at optimal debulking surgery (upfront or interval debulking). Stage IV patients must have had either a biopsy and/or upfront or interval debulking surgery. * Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function). * Patients who have completed first line platinum (e.g. carboplatin or cisplatin), containing therapy (intravenous or intraperitoneal) prior to randomisation: * Patients must have, in the opinion of the investigator, clinical complete response or partial response and have no clinical evidence of disease progression on the post treatment scan or rising CA-125 level, following completion of this chemotherapy course. Patients with stable disease on the post-treatment scan at completion of first line platinum-containing therapy are not eligible for the study. * Patients must be randomized within 8 weeks of their last dose of chemotherapy Exclusion Criteria: * BRCA1 and/or BRCA2 mutations that are considered to be non detrimental (e.g. "Variants of uncertain clinical significance" or "Variant of unknown significance" or "Variant, favor polymorphism" or "benign polymorphism" etc). * Patients with early stage disease (FIGO Stage I, IIA, IIB or IIC) * Stable disease or progressive disease on the post-treatment scan or clinical evidence of progression at the end of the patient's first line chemotherapy treatment. * Patients where more than one debulking surgery has been performed before randomisation to the study. (Patients who, at the time of diagnosis, are deemed to be unresectable and undergo only a biopsy or oophorectomy but then go on to receive chemotherapy and interval debulking surgery are eligible). * Patients who have previously been diagnosed and treated for earlier stage ovarian, fallopian tube or primary peritoneal cancer. * Patients who have previously received chemotherapy for any abdominal or pelvic tumour, including treatment for prior diagnosis at an earlier stage for their ovarian, fallopian tube or primary peritoneal cancer. (Patients who have received prior adjuvant chemotherapy for localised breast cancer may be eligible, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease). * Patients with synchronous primary endometrial cancer unless both of the following criteria are met: 1) stage \<2 2) less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with Stage IA grade 1 or 2 endometrioid adenocarcinoma. Patients with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible.

Primary outcome measure(s)

Trial sites (177)

FacilityCityRegionStatus
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.

Official registry record

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 the UK