Study of Niraparib and TSR-042 in Recurrent Endometrial Cancer

Sponsor
University Health Network, Toronto
Study ID
NCT03016338
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    200 or 300 mg daily PO, for 21 day cycle
  • TSR-042 — DRUG
    500 mg once intravenously on day 1 of cycle (From cycle 1-4 followed by 1000 mg intravenously every 6 weeks for maximum of 2 yrs)

Study Details

This is a phase 2 study of investigational drug niraparib and TSR-042 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.

Key Dates

Start date
Nov 6, 2017
Status verified
Jan 2024
Primary completion
Jan 5, 2021
Completion
Dec 31, 2025

Study Design

Enrollment
51 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib +TSR-042
    200/300 mg Niraparib by mouth once a day for 21 days cycle. 500 mg of TSR-042 intravenously on the first day of each cycle.

Primary Outcome Measure

To determine the antitumor activity according to RECIST v 1.1 [ Time Frame: 16 weeks ]

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