A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study
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|ClinicalTrials.gov Identifier: NCT04641247|
Recruitment Status : Not yet recruiting
First Posted : November 23, 2020
Last Update Posted : November 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Neoplasms Breast Neoplasms||Drug: Niraparib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Participants will receive niraparib once a day, continuously throughout each 90-day cycle.|
|Masking:||None (Open Label)|
|Masking Description:||This will be an open-label study.|
|Official Title:||An Open-Label, Multicenter, Long-term Treatment Extension Study in Subjects Who Have Completed a Prior GlaxoSmithKline/TESARO-Sponsored Niraparib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Niraparib|
|Estimated Study Start Date :||February 24, 2021|
|Estimated Primary Completion Date :||February 26, 2026|
|Estimated Study Completion Date :||February 26, 2026|
Experimental: Participants receiving niraparib
Participants will receive niraparib once a day, continuously throughout each 90-day cycle until one of the following occurs: disease progression, unacceptable toxicity, initiation of new anticancer therapy that was not part of the parent study, withdrawal of consent, discontinuation at the discretion of the Investigator, noncompliance with protocol, death, or discontinuation for any other reason. The doses provided in this long-term treatment extension study will be those defined in the parent study for each enrolled participant. The starting dose of niraparib will be the same as the assigned dose and regimen that were given in the parent study.
Niraparib tablets or capsules will be given once a day via the oral route.
- Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) [ Time Frame: Up to 5 years ]AEs, SAEs and AESI will be collected.
- Number of participants with clinically significant changes in Eastern Co-operative Oncology Group (ECOG) performance status [ Time Frame: Up to 5 years ]The performance status will be assessed using ECOG scale, where Grade 0 (fully active), Grade 1 (restricted in physically strenuous activity), Grade 2 (ambulatory and capable of all self-care), Grade 3 (capable of only limited self-care) and Grade 4 (completely disabled). Number of participants with clinically significant changes in ECOG performance status will be summarized.
- Number of participants with clinically significant changes in hematology and clinical chemistry parameters [ Time Frame: Up to 5 years ]Blood samples will be collected for the analysis of hematology and clinical chemistry parameters.
- Number of participants with clinically significant changes in vital signs [ Time Frame: Up to 5 years ]Number of participants with clinically significant changes in vital signs will be assessed.
- Number of participants with clinically significant changes in physical examination [ Time Frame: Up to 5 years ]Number of participants with clinically significant changes in physical examination will be assessed.
- Number of participants with use of concomitant medications [ Time Frame: Up to 5 years ]Number of participants using concomitant medications will be assessed.
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): NCT04641247
|Contact: US GSK Clinical Trials Call Center||877-379-3718||GSKClinicalSupportHD@gsk.com|
|Contact: EU GSK Clinical Trials Call Center||+44 (0) 20 89904466||GSKClinicalSupportHD@gsk.com|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|