Study of Niraparib in Recurrent Endometrial Cancer

Official Title

A Phase II, Open Label Study of the Poly(ADP-ribose) Polymerase Inhibitor Niraparib (MK 4827) in Recurrent Endometrial Cancer

Summary:

This is a phase 2 study of investigational drug niraparib in patients with advanced/recurrent endometrial cancer. The purpose of this study is to determine whether blocking a protein called poly (ADP-ribose) polymerase (PARP) with niraparib provides clinical benefit in patients with recurrent endometrial cancer, as well as to explore the possible impact of phosphatase and tensin homolog (PTEN) loss (loss of function of the PTEN gene) on blocking PARP with niraparib.

Trial Description

Primary Outcome:

  • Clinical benefit rate
Secondary Outcome:
  • Number of side effects
  • Overall response rate
  • Duration of response
  • Progression free survival rate
  • Overall survival rate
The study will first enroll patients with recurrent endometrial cancer regardless of PTEN status. If this patient population does not meet the criteria for clinical efficacy, retrospective analysis of PTEN status will be done and the study will potentially continue with a focus on participants with PTEN loss. Participants will be screened for eligibility by standard safety tests and procedures within 28 days of the start of the study drug. Tests and procedures done for research purposes only during this time include archival tumour tissue collection for biomarker/genetic research including PTEN analysis, and blood sample collection for analysis in the even the participant develops myelodysplastic syndrome) MDS or acute myeloid leukemia (AML). Eligible participants will take niraparib capsules or tablets by mouth, at 300 mg, once a day, every day of every 28 day cycle. While receiving the study treatment, participants will be asked to visit the study site on Days 1, 8, 15, and 21 of Cycle 1, Days 1 and 15 of Cycle 2, and Day 1 of Cycle 3 and future cycles for safety tests and procedures. If, at any time, participants develop (or is suspected to have developed) MDS/AML, a mandatory bone marrow aspirate/biopsy will be done for testing to confirm diagnosis. When participants are taken off the study treatment permanently, they will be asked to return to the study site for an End of Study Treatment visit to have tests and procedures done for safety purposes. Participants who are taken off the study treatment for any reason other than disease progression will continue to have radiological assessments every 12 weeks until disease progression. Participants will continue to be followed up for side effects weekly in the first 4 weeks, then monthly until resolution.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society