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ACTIVE NOT RECRUITING
NCT03016338
PHASE2

Study of Niraparib and TSR-042 in Recurrent Endometrial Cancer

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase II, Open Label Study of the Poly(ADP-ribose) Polymerase Inhibitor Niraparib in Monotherapy or in Combination With Anti-PD1 Inhibitor TSR-042 in Recurrent Endometrial Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

51

Start Date

2017-11-06

Completion Date

2026-12

Last Updated

2026-06-23

Healthy Volunteers

No

Interventions

DRUG

Niraparib

200 or 300 mg daily PO, for 21 day cycle

DRUG

TSR-042

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)

Locations (7)

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Cancer Centre of Southeastern Ontario at Kingston

Kingston, Ontario, Canada

London Regional Cancer Centre

London, Ontario, Canada

Sunnybrook Research Institute, Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

McGill University Health Centre - Glen Site

Montreal, Quebec, Canada