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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
~1540

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,456 Previous Clinical Trials
482,822 Total Patients Enrolled
5 Trials studying Endometrial Cancer
918 Patients Enrolled for Endometrial Cancer
Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,499 Total Patients Enrolled
3 Trials studying Endometrial Cancer
88 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Niraparib come with any notable safety concerns?

"Our evaluation of Niraparib has deemed its safety to be a 2 on the 1-3 scale, as this is a Phase 2 trial. Consequently, there are data points that suggest it is safe yet no clinical evidence suggesting efficacy."

Answered by AI

How widely is this research endeavor being conducted across North America?

"This trial is being held at 7 distinct medical sites, including Juravinski Cancer Centre in Hamilton, Cancer Centre of Southeastern Ontario at Kingston in Kingston and Princess Margaret Cancer Centre in Toronto. Additionally, 4 more facilities are participating."

Answered by AI

Is there still an opportunity for participants to join this experiment?

"Recruitment for this trial has been concluded, with the last update to its page occurring on November 18th 2021. For those searching for other clinical trials involving endometrial neoplasms, there are currently 285 studies actively admitting participants and 115 that allow Niraparib as a treatment option."

Answered by AI

To what extent have researchers explored the potential of Niraparib through clinical trials?

"Presently, 115 clinical trials are actively studying the efficacy of Niraparib with 14 in their final phase. These studies span 3320 locations globally, particularly concentrated around Washington D.C.."

Answered by AI

How many participants are enrolled in this experiment?

"This research effort has since concluded its participant recruitment. The trial was initiated in November of 2017 and last updated in 18th 2021. Alternately, if you are interested in similar studies, there are currently 285 clinical trials recruiting for endometrial neoplasms and 115 clinical trials with Niraparib as the primary drug being studied."

Answered by AI

What is the predominant application of Niraparib?

"Niraparib is typically used to treat primary peritoneal cancer, but has also been proven as an effective therapy for advanced mismatch repair-deficient (dmmr) endometrial cancer, disease that has progressed during or following platinum-containing chemotherapy and fallopian tubes cancer."

Answered by AI
~7 spots leftby Mar 2025