Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer

Recruiting Phase 3 Interventional Study
Fallopian Tube Endometrioid Adenocarcinoma Fallopian Tube High Grade Serous Adenocarcinoma Fallopian Tube Malignant Mixed Mesodermal (Mullerian) Tumor FIGO Stage III Ovarian Cancer 2014 FIGO Stage IV Ovarian Cancer 2014 Ovarian Carcinoma Ovarian Carcinosarcoma Ovarian High Grade Endometrioid Adenocarcinoma Ovarian High Grade Serous Adenocarcinoma Primary Peritoneal Carcinosarcoma Primary Peritoneal Endometrioid Adenocarcinoma Primary Peritoneal High Grade Serous Adenocarcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
880 (estimated)
Sponsor
NRG Oncology · Other
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About This Trial
This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Be…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patients with newly diagnosed, pathologically confirmed, Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian cancer of the following types: * High grade serous * High grade endometrioid (excluding tumors that are known mismatch repair deficient/microsat…
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