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

• ClinicalTrials.gov Identifier: NCT04641247
• Recruitment Status: Not yet recruiting
• First Posted: November 23, 2020
• Last Update Posted: November 27, 2020
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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, NCT03329001, NCT02657889) that has fulfilled the requirements for the primary objective.

Condition or disease	Intervention/treatment	Phase
Ovarian Neoplasms; Breast Neoplasms	Drug: Niraparib	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 500 participants
• Allocation: N/A
• 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.
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm

Intervention/treatment

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.

Drug: Niraparib; Niraparib tablets or capsules will be given once a day via the oral route.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. Number of participants with use of concomitant medications [ Time Frame: Up to 5 years ]
   Number of participants using concomitant medications will be assessed.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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).

Contacts and Locations

Contacts

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT04641247
• Other Study ID Numbers: 213409
• First Posted: November 23, 2020
• Last Update Posted: November 27, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• URL: http://clinicalstudydatarequest.com

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:

Adverse events; Open-label extension; Parent study; Niraparib; Safety

Additional relevant MeSH terms:

Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders; Niraparib; Poly(ADP-ribose) Polymerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents