Olaparib for Stage III or IV Ovarian Cancer

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
Who this trial is looking for

This trial is looking for patients with certain types of stage III or IV ovarian cancer. Participants will take a medication called olaparib for either one or two years to see how well it works alone or with another drug called bevacizumab.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with stage III or IV ovarian cancer.
  • I have a known BRCA1 or BRCA2 gene mutation.
  • I have completed at least 4 cycles of platinum-based chemotherapy.
  • I have had surgery to remove my tumor.
  • I am at least 18 years old.
  • I have no evidence of disease progression after chemotherapy.
  • I am not pregnant or nursing.
  • My blood counts meet the trial requirements.

You may not be able to join if

  • I have received a PARP inhibitor before.
  • I have an active infection requiring antibiotics.
  • I have a history of myelodysplastic syndrome or acute myeloid leukemia.
  • I have had a heart attack in the past 6 months.
  • I cannot swallow pills.
  • I have current symptoms of heart disease.
  • I have an unresolved abdominal issue like a fistula or obstruction.
  • I am using certain strong or moderate medications that affect liver enzymes.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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…
Contacts

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