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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04641247

Collaborator

(none)

Enrollment

Locations

Arm

54.9

Anticipated Duration (Months)

1.1

Patients Per Site

Patients Per Site Per Month

Study Details

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, NCT03308942, 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

Actual Enrollment :

26 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.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

Actual Study Start Date :

Apr 16, 2021

Anticipated Primary Completion Date :

Nov 13, 2025

Anticipated Study Completion Date :

Nov 13, 2025

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.

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Tucson	Arizona	United States	85710
2	GSK Investigational Site	West Hollywood	California	United States	90048
3	GSK Investigational Site	Whittier	California	United States	90603
4	GSK Investigational Site	Jacksonville	Florida	United States	32224
5	GSK Investigational Site	Atlanta	Georgia	United States	30342
6	GSK Investigational Site	Harvey	Illinois	United States	60426
7	GSK Investigational Site	Boston	Massachusetts	United States	02115
8	GSK Investigational Site	Morristown	New Jersey	United States	07962-1956
9	GSK Investigational Site	Lake Success	New York	United States	11042
10	GSK Investigational Site	Charlotte	North Carolina	United States	28204
11	GSK Investigational Site	Cleveland	Ohio	United States	44195
12	GSK Investigational Site	Graz		Austria	A-8036
13	GSK Investigational Site	Wien		Austria	1090
14	GSK Investigational Site	Vancouver	British Columbia	Canada	V5Z 4E6
15	GSK Investigational Site	Toronto	Ontario	Canada	M5G 2M9
16	GSK Investigational Site	Montreal	Quebec	Canada	H4A 3J1
17	GSK Investigational Site	Odense		Denmark	5000
18	GSK Investigational Site	Nantes cedex		France	44202
19	GSK Investigational Site	Nice Cedex 2		France	06189
20	GSK Investigational Site	Haifa		Israel	3109601
21	GSK Investigational Site	Cremona	Lombardia	Italy	26100
22	GSK Investigational Site	Madrid		Spain	28046
23	GSK Investigational Site	Marid		Spain	28040