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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 676 → 695 locations Eligibility criteria expanded, about 38 wordsv6 Show 1 more changeShow less
    • Eligibility criteria expanded, about 38 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 672 to 676v5
  3. Study sites: 636 to 672v4
  4. Study sites: 511 to 636v3
  5. Trial status: Not Yet Recruiting to Recruiting Primary endpoint revised · Study sites: 0 to 511 · Completion date: Dec 31, 2035 to Dec 31, 2034 · 4 morev2 Show 7 more changesShow less
    • Primary endpoint revised
    • Study sites: 0 to 511
    • Completion date: Dec 31, 2035 to Dec 31, 2034
    • Start date changed from estimate of Jan 16, 2025 to Mar 12, 2025
    • Secondary endpoints: 3 to 5
    • Study description expanded, about 18 words
    • Eligibility criteria shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
NRG Oncology
67 trials monitored
See 5 trials at risk
Ovarian Cancer
1,245 trials monitored
See 80 trials at risk
Sarcoma
951 trials monitored
See 56 trials at risk
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.
Trial Details
NCT Number NCT06580314
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI)
Conditions 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 +4 more
Enrollment 880 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov