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Advanced Ovarian Cancer Treatment Study

Clinical Trial Title: 
A study of niraparib maintenance treatment in patients with advanced ovarian cancer following response on front-line platinum-based chemotherapy.
Clinical Trial Protocol ID: 
16011404
Clinical Trial Investigator Name: 
Summer B. Dewdney, MD
Clinical Trial Protocol Description: 

Subjects are being asked to be in this research study because they have ovarian, primary peritoneal or fallopian tube cancer. This study is being done to help find out if niraparib can help delay worsening of cancer among patients who had a good response to previous treatment with a platinum-type chemotherapy drug.

Subjects who agree to be in this study will either take the study drug capsules (niraparib) or placebo capsules (containing no active drug) by mouth once daily. The placebo capsules look exactly like the study drug, but do not contain any active drug.

A computer will randomly assign subjects (by chance, like pulling a name out of a hat) to receive either the study drug or placebo capsules. Subjects will have a 66.7% (2 in 3) chance of receiving study drug and a 33.3% (1 in 3) chance of receiving placebo.

This is a double-blind study, which means that neither the subject nor the study doctor will know if they are receiving study drug or placebo (except in an emergency situation where knowledge of the treatment assignment is required to treat a study drug-related medical event). If the doctor feels that it is necessary to find out whether subjects have been assigned to niraparib or placebo, there is a process that will need to be followed.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Are a female, are 18 years of age or older, are able to understand the study procedures and agree to participate in the study by providing written informed consent.
  • Have high-grade serous or endometrioid, or high-grade predominantly serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is stage III or IV.
  • Have inoperable stage III and IV disease are eligible; all stage IV patients with operable disease are eligible.
  • Can be randomized within 12 weeks of the first day of the last cycle of chemotherapy.

You will be excluded from the study if any of the following criteria apply to you:

  • Have undergone more than two debulking surgeries.
  • Have a condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results or interfere with your participation for the full duration of the study treatment.
  • Have received prior treatment with a known PARP inhibitor or have participated in a different study where any treatment arm included administration of a known PARP inhibitor.
  • Have received bevacizumab with your first-line platinum based therapy.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Gynecologic Cancers
Contact Phone: 
(312) 942-2417 or (312) 942-7254
Contact Name: 
Lois Winkelman or Judith Dybinski