Study of Niraparib and TSR-042 in Recurrent Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT03016338|
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : December 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: Niraparib Drug: TSR-042||Phase 2|
The purpose of this trial is to elucidate whether the PARP inhibition approach with niraparib, or the combination of niraparib and TSR-042, provides clinical benefit in patients with recurrent endometrial cancer.
The trial is designed as a multicenter, open-label, phase II study of niraparib in monotherapy or in combination with anti-PD1 inhibitor TSR-042 in recurrent endometrial cancer. Patients must have received prior platinum based chemotherapy.
The study will initially enroll patients with recurrent endometrial cancer to the niraparib monotherapy cohort not selected according to the PTEN status (cohort I).
Once the initial assessment with niraparib monotherapy is completed (inclusion of 22 evaluable patients),Additional 22 patients will be enrolled in the combination arm with niraparib and TSR-042 (cohort II).
Eligible participants will take niraparib capsules or tablets by mouth 300/200 mg, once a day, every day of every 21 day cycle.Participant will receive TSR-042 500 mg( intravenously) on the first day of each cycle for cycle 1 to 4. Followed by 1000 mg every 2 cycle for every 6 weeks for maximum of 2 yrs.
While receiving the study treatment, participants will be asked to visit the study site on Days 1, 8, 15 of Cycle 1.Cycle 2 onward Days 1 and 15 and future cycles for safety tests and procedures. If, at any time, participants develop (or is suspected to have developed) MDS/AML, a mandatory bone marrow aspirate/biopsy will be done for testing to confirm diagnosis.
When participants are taken off the study treatment permanently, they will be asked to return to the study site for an End of Study Treatment visit to have tests and procedures done for safety purposes.
Participants who are taken off the study treatment for any reason other than disease progression will continue to have radiological assessments every 8 weeks until disease progression. Participants will continue to be followed up for side effects weekly in the first 4 weeks, then monthly until resolution.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 6, 2017|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||December 2023|
Experimental: Niraparib +TSR-042
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.
200 or 300 mg daily PO, for 21 day cycle
Other Name: MK4827
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)
- Clinical benefit rate [ Time Frame: 16 weeks ]
- Number of side effects [ Time Frame: 5 years ]
- Overall response rate [ Time Frame: 5 years ]
- Duration of response [ Time Frame: 5 years ]
- Progression free survival rate [ Time Frame: 5 years ]
- Overall survival rate [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016338
|Contact: Stephanie Lheureux, M.D.||416-946-2818||Stephanie.Lheureux@uhn.ca|
|Contact: Amit M Oza, M.D.||416-946-2818||Amit.Oza@uhn.ca|
|Tom Baker Cancer Centre||Recruiting|
|Calgary, Alberta, Canada, T2N 4N2|
|Contact: Prafull Ghatage, M.D. 403-521-3721|
|Principal Investigator: Prafull Ghatage|
|Juravinski Cancer Centre||Active, not recruiting|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Centre of Southeastern Ontario at Kingston||Recruiting|
|Kingston, Ontario, Canada, K7L 5P9|
|Contact: Jim Biagi, M.D. 613-44-2630|
|Principal Investigator: Jim Biagi, M.D.|
|London Regional Cancer Centre||Recruiting|
|London, Ontario, Canada, N6A 4L6|
|Contact: Stephen Welch, M.D. 519-685-8640|
|Sunnybrook Research Institute, Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Helen MacKay, M.D. 416-480-5145|
|Principal Investigator: Helen MacKay, M.D.|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 1M9|
|Contact: Stephanie Lheureux, M.D. 416-946-2818|
|Principal Investigator: Stephanie Lheureux, M.D.|
|McGill University Health Centre - Glen Site||Recruiting|
|Montréal, Quebec, Canada, H3A 3J1|
|Contact: Lucy Gilbert, M.D. 514-934-1934 ext 34049|
|Principal Investigator: Lucy Gilbert, M.D.|
|Study Director:||Amit M Oza, M.D.||UHN - Princess Margaret Cancer Centre|