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Back|NCT06580314Recruiting
Official Title

A Phase III Trial of One vs. Two Years of Maintenance Olaparib, With or Without Bevacizumab, in Patients With BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-Based Chemotherapy

Phase
Phase 3
Sponsor
NRG Oncology
Enrollment
880
Timeline
Mar 2025 → Dec 2034
About This Study

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. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib for one year with or without bevacizumab may be effective in treating patients with BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer, when compared to two years of olaparib.

Eligibility Criteria

Inclusion Criteria

  • 1Patients with newly diagnosed, pathologically confirmed, Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian cancer of the following types:
  • 2High grade serous
  • 3High grade endometrioid, and/or
  • 4Other epithelial ovarian cancer with BRCA1/2 deleterious alteration (germline or somatic)
  • 5Submission of pathology report is required
  • 6Ovarian cancer = ovarian, fallopian, or primary peritoneal cancer
  • 7Patients must have:
  • 8Documented variant (tumor or germline) in BRCA1 or BRCA2 that is predicted to be pathogenic or suspected pathogenic (deleterious alteration)
  • 9Submission of testing report is required. OR
  • 10BRCA 1/2 wildtype AND known HRD deficient tumor determined by any commercial or academic, Clinical Laboratory Improvement Act (CLIA)-certified laboratory (e.g., Myriad MyChoice©)
  • 11Submission of testing report is required
  • 12Patient must have undergone cytoreductive surgery (primary or interval)
  • 13Patients must have completed first line platinum-based therapy prior to registration:
  • 14Platinum based chemotherapy course must have consisted of a minimum of 4 treatment cycles and a maximum of 9, although it is strongly recommended that patients receive at least 6 cycles unless medically contraindicated
  • 15For those receiving less than 6 cycles of platinum-based therapy, the reason for this must be documented and could include hematologic toxicity or non-hematologic toxicities directly related to therapy
  • 16Intravenous, intraperitoneal, or neoadjuvant platinum-based chemotherapy is allowed; for weekly therapy, three weeks are considered one cycle
  • 17Patients must not have received an investigational agent during their first line course of chemotherapy
  • 18Patients must have, in the opinion of the investigator, no clinical evidence of disease progression following completion of this chemotherapy course (partial or complete response to platinum-based chemotherapy)
  • 19Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression following completion of this chemotherapy course (partial or complete response to platinum-based chemotherapy)
  • 20Patients must be randomized at least 3 weeks and no more than 12 weeks after their last dose of chemotherapy (last dose is the day of the last infusion of platinum agent)
  • 21No previous treatment with a PARP inhibitor, including olaparib, niraparib, and rucaparib
  • 22Age ≥ 18
  • 23Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • 24Not pregnant and not nursing
  • 25Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
  • 26Platelets ≥ 100,000 cells/mm\^3
  • 27Hemoglobin ≥ 9 g/dl
  • 28Creatinine clearance (CrCL) of \> 30 mL/min by the Cockcroft-Gault formula
  • 29Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
  • 30Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN
  • 31Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
  • 32No active infection requiring parental antibiotic(s)
  • 33No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
  • 34No current inability to swallow orally administered medication
  • 35No history of myelodysplastic syndrome and/or acute myeloid leukemia
  • 36No history of allogeneic bone marrow transplant
  • 37No concomitant use of strong or moderate CYP3A inducers
  • 38No known hypersensitivity to olaparib or any of the excipients of the product

Locations

636 sites participating in this study

Emory University Hospital Midtown

Atlanta, Georgia 30308

Recruiting

Beryl Manning-Geist

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Beryl Manning-Geist

Emory Saint Joseph's Hospital

Atlanta, Georgia 30342

Recruiting

Beryl Manning-Geist

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →