Study of Niraparib in Recurrent Endometrial Cancer
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|ClinicalTrials.gov Identifier: NCT03016338|
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : July 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: Niraparib||Phase 2|
The study will first enroll patients with recurrent endometrial cancer regardless of PTEN status. If this patient population does not meet the criteria for clinical efficacy, retrospective analysis of PTEN status will be done and the study will potentially continue with a focus on participants with PTEN loss.
Participants will be screened for eligibility by standard safety tests and procedures within 28 days of the start of the study drug. Tests and procedures done for research purposes only during this time include archival tumor tissue collection for biomarker/genetic research including PTEN analysis, and blood sample collection for analysis in the even the participant develops myelodysplastic syndrome) MDS or acute myeloid leukemia (AML).
Eligible participants will take niraparib capsules or tablets by mouth, at 300 mg, once a day, every day of every 28 day cycle.
While receiving the study treatment, participants will be asked to visit the study site on Days 1, 8, 15, and 21 of Cycle 1, Days 1 and 15 of Cycle 2, and Day 1 of Cycle 3 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 12 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 (MK 4827) in Recurrent Endometrial Cancer|
|Actual Study Start Date :||November 6, 2017|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||September 2022|
300 mg, orally (by mouth), once a day, every day of every 28 day cycle.
200 or 300 mg daily PO, for 28 day cycle
Other Name: MK4827
- 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||Recruiting|
|Hamilton, Ontario, Canada, L8V 5C2|
|Contact: Waldo Jimenez, M.D. 905-387-9495|
|Principal Investigator: Waldo Jimenez, M.D.|
|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|