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A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study

Phase 2
Active, not recruiting
Conditions
Ovarian Neoplasms
Breast Neoplasms
Interventions
Registration Number
NCT04641247
Lead Sponsor
GlaxoSmithKline
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
26
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).

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Participants receiving niraparibNiraparibParticipants 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.
Primary Outcome Measures
NameTimeMethod
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 statusUp 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 vital signsUp 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 examinationUp to 5 years

Number of participants with clinically significant changes in physical examination will be assessed.

Number of participants with use of concomitant medicationsUp to 5 years

Number of participants using concomitant medications will be assessed.

Number of participants with clinically significant changes in hematology and clinical chemistry parametersUp to 5 years

Blood samples will be collected for the analysis of hematology and clinical chemistry parameters.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

GSK Investigational Site

🇪🇸

Madrid, Spain

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