Breast Neoplasms, Ovarian Neoplasms
Conditions
Keywords
Adverse events, Open-label extension, Parent study, Niraparib, Safety
Brief summary
This is a global extension study to provide continued access to niraparib and further characterize the long-term safety of niraparib treatment in participants who are currently receiving treatment with niraparib within GlaxoSmithKline/TESARO-sponsored studies (NCT01847274, NCT02354586, NCT01905592, NCT03308942, NCT02657889) that has fulfilled the requirements for the primary objective.
Interventions
DRUGNiraparib
Niraparib tablets or capsules will be given once a day via the oral route.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This will be an open-label study.
Intervention model description
Participants will receive niraparib once a day, continuously throughout each 90-day cycle.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant is able to understand the study procedures and agrees to participate in the study by providing written informed consent. * Participant is willing and able to comply with scheduled visits, treatment plans, and any other study procedures. * Participant is currently receiving treatment with niraparib (as monotherapy or in combination) in a GlaxoSmithKline/TESARO-sponsored study that has fulfilled the requirements for the primary objective. * Participant is currently benefiting from treatment with niraparib as assessed by the Investigator according to the parent study protocol requirements. * Participants of childbearing potential who are sexually active and their partners must agree to the use of an effective form of contraception throughout their participation during study treatment through 180 days after last dose of study drug.
Exclusion criteria
* Participant has been permanently discontinued from niraparib treatment in the parent study for any reason. * Participant currently has unresolved toxicities for which niraparib dosing has been interrupted in the parent study. Participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow niraparib treatment to resume. * Participant is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Participant is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use during niraparib treatment and for 30 days after receiving the final dose of study treatment).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) | 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 | 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 | 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 | 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 | 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 | Up to 5 years | Number of participants using concomitant medications will be assessed. |
Countries
Austria, Canada, Denmark, France, Israel, Italy, Spain, United States
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
STUDY_DIRECTORGSK Clinical Trials
GlaxoSmithKline
Outcome results
None listed