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PARP Inhibitor

Niraparib + TSR-042 for Endometrial Cancer

Phase 2
Waitlist Available
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Group (ECOG) performance status ≤ 2
Histologically confirmed epithelial endometrial cancer, excluding endometrial sarcoma, carcinosarcoma, clear cell, mixed, and adenosquamous tumors
Must not have
Hormonal therapy within 2 weeks of starting study treatment
Previous treatment with PARP inhibitors or targeted therapy against the homologous recombination pathway
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing an investigational drug to see if it can help treat endometrial cancer that has come back or is advanced. The drug works by targeting a protein called PARP, and researchers want to see if it is more effective in patients whose cancer has a specific genetic change.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects may include nausea, fatigue, blood count changes (like anemia), gastrointestinal issues (such as constipation or diarrhea), heart palpitations or changes in heartbeat rhythm due to niraparib; immune-related reactions such as skin rash or thyroid dysfunction from TSR-042.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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I have a specific type of uterine cancer, not including certain rare forms.
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My cancer has worsened after my last treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not taken hormonal therapy in the last 2 weeks.
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I have been treated with PARP inhibitors or drugs targeting DNA repair.
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I have had a fistula or am at high risk of developing one.
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I have a history of HIV or active hepatitis.
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I have been treated with specific immunotherapy before.
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I do not have any unmanaged ongoing illnesses.
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I haven't had chemotherapy or biologic agents in the last 4 weeks.
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I have not had a bowel obstruction in the last 3 months.
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I have a history of MDS or AML.
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I have a weakened immune system or a history of certain infections.
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I have a history of lung scarring or fibrosis.
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I have not received a live vaccine in the last 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To determine the antitumor activity according to RECIST v 1.1
Secondary study objectives
Duration of response
Number of side effects
Overall response rate
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
2018
Completed Phase 4
~2400

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,527 Previous Clinical Trials
503,495 Total Patients Enrolled
4 Trials studying Endometrial Cancer
312 Patients Enrolled for Endometrial Cancer
Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,505 Total Patients Enrolled
3 Trials studying Endometrial Cancer
117 Patients Enrolled for Endometrial Cancer
Amit M Oza, M.D.Study DirectorUHN - Princess Margaret Cancer Centre

Media Library

Niraparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03016338 — Phase 2
Endometrial Cancer Research Study Groups: Niraparib +TSR-042
Endometrial Cancer Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT03016338 — Phase 2
Niraparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03016338 — Phase 2
~6 spots leftby Dec 2025
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