Niraparib + TSR-042 for Endometrial Cancer

Recruiting at 6 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University Health Network, Toronto

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

Duration: 21-day cycles, up to 2 years

51 Participants Needed

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.

Research Team

Amit M Oza, M.D.

Principal Investigator

UHN - Princess Margaret Cancer Centre

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive niraparib monotherapy or in combination with TSR-042. Niraparib is taken daily, and TSR-042 is administered intravenously on specific days of the cycle.

21-day cycles, up to 2 years

Visits on Days 1, 8, 15 of Cycle 1; Days 1 and 15 from Cycle 2 onward

End of Study Treatment

Participants undergo tests and procedures for safety purposes after discontinuing study treatment.

Follow-up

Participants are monitored for side effects and undergo radiological assessments every 8 weeks until disease progression. Follow-up for side effects is weekly for the first 4 weeks, then monthly until resolution.

5 years

Treatment Details

Interventions

• Niraparib
• TSR-042

Trial Overview 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.

Participant Groups

Group I: Niraparib +TSR-042 Experimental Treatment 2 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

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Tesaro, Inc.

Industry Sponsor

Trials

57

Recruited

10,600+