Study of Niraparib and TSR-042 in Recurrent Endometrial Cancer
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ClinicalTrials.gov Identifier: NCT03016338 |
Recruitment Status :
Active, not recruiting
First Posted : January 10, 2017
Last Update Posted : January 30, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | January 6, 2017 | ||||
First Posted Date ICMJE | January 10, 2017 | ||||
Last Update Posted Date | January 30, 2024 | ||||
Actual Study Start Date ICMJE | November 6, 2017 | ||||
Actual Primary Completion Date | January 5, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
To determine the antitumor activity according to RECIST v 1.1 [ Time Frame: 16 weeks ] To determine the antitumor activity of single agent niraparib and of niraparib in combination with TSR-042 in women with metastatic endometrial cancer who has received prior platinum-based chemotherapy via assessment of clinical benefit rate (complete response, partial response or stable disease ≥16 weeks), according to RECIST v 1.1.
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Original Primary Outcome Measures ICMJE |
Clinical benefit rate [ Time Frame: 16 weeks ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of Niraparib and TSR-042 in Recurrent Endometrial Cancer | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | 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. | ||||
Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Endometrial Cancer | ||||
Intervention ICMJE |
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Study Arms ICMJE | 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.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
51 | ||||
Original Estimated Enrollment ICMJE |
44 | ||||
Estimated Study Completion Date ICMJE | December 2025 | ||||
Actual Primary Completion Date | January 5, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03016338 | ||||
Other Study ID Numbers ICMJE | NEC | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | University Health Network, Toronto | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | University Health Network, Toronto | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Tesaro, Inc. | ||||
Investigators ICMJE |
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PRS Account | University Health Network, Toronto | ||||
Verification Date | January 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |