Niraparib + TSR-042 for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for patients with advanced or recurrent endometrial cancer who have had at least one platinum-based chemotherapy. They must show disease progression, have a performance status ≤ 2, and measurable disease. Exclusions include those with certain medical conditions like fistulas, lung diseases, recent transfusions or surgeries, MDS/AML history, bowel obstruction within 3 months, immunodeficiency including HIV/Hepatitis B/C active infections, brain metastases unless stable over 28 days without steroids needed for control of symptoms.

Inclusion Criteria

My organs and bone marrow are functioning normally.

I have been on a stable dose of corticosteroids for at least 4 weeks.

I can take care of myself and am up and about more than half of my waking hours.

+7 more

Exclusion Criteria

I have not taken hormonal therapy in the last 2 weeks.

My brain metastases have been stable for a set period.

I have been treated with PARP inhibitors or drugs targeting DNA repair.

+18 more

Participant Groups

The study tests niraparib in combination with TSR-042 to see if blocking the PARP protein can benefit those with recurrent endometrial cancer. It also examines how PTEN gene loss affects treatment response. This phase 2 trial will assess clinical benefits and potentially pave the way for new therapeutic strategies.

1Treatment groups

Experimental Treatment

Group I: Niraparib +TSR-042Experimental Treatment2 Interventions

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.

Niraparib is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Zejula for:

Maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
Maintenance treatment of adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy

🇺🇸 Approved in United States as Zejula for:

Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status

🇨🇦 Approved in Canada as Zejula for:

Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy