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

Primary Purpose

Ovarian Neoplasms, Breast Neoplasms

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Niraparib
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Neoplasms focused on measuring Adverse events, Open-label extension, Parent study, Niraparib, Safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants receiving niraparib

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)
AEs, SAEs and AESI will be collected.
Number of participants with clinically significant changes in Eastern Co-operative Oncology Group (ECOG) performance status
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
Blood samples will be collected for the analysis of hematology and clinical chemistry parameters.
Number of participants with clinically significant changes in vital signs
Number of participants with clinically significant changes in vital signs will be assessed.
Number of participants with clinically significant changes in physical examination
Number of participants with clinically significant changes in physical examination will be assessed.
Number of participants with use of concomitant medications
Number of participants using concomitant medications will be assessed.

Secondary Outcome Measures

Full Information

First Posted
November 20, 2020
Last Updated
July 20, 2022
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT04641247
Brief Title
A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 16, 2021 (Actual)
Primary Completion Date
November 13, 2025 (Anticipated)
Study Completion Date
November 13, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms, Breast Neoplasms
Keywords
Adverse events, Open-label extension, Parent study, Niraparib, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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.
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants receiving niraparib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Niraparib
Intervention Description
Niraparib tablets or capsules will be given once a day via the oral route.
Primary Outcome Measure Information:
Title
Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)
Description
AEs, SAEs and AESI will be collected.
Time Frame
Up to 5 years
Title
Number of participants with clinically significant changes in Eastern Co-operative Oncology Group (ECOG) performance status
Description
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.
Time Frame
Up to 5 years
Title
Number of participants with clinically significant changes in hematology and clinical chemistry parameters
Description
Blood samples will be collected for the analysis of hematology and clinical chemistry parameters.
Time Frame
Up to 5 years
Title
Number of participants with clinically significant changes in vital signs
Description
Number of participants with clinically significant changes in vital signs will be assessed.
Time Frame
Up to 5 years
Title
Number of participants with clinically significant changes in physical examination
Description
Number of participants with clinically significant changes in physical examination will be assessed.
Time Frame
Up to 5 years
Title
Number of participants with use of concomitant medications
Description
Number of participants using concomitant medications will be assessed.
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
GSK Investigational Site
City
West Hollywood
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
GSK Investigational Site
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
GSK Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
GSK Investigational Site
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
GSK Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
GSK Investigational Site
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962-1956
Country
United States
Facility Name
GSK Investigational Site
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
GSK Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
GSK Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
GSK Investigational Site
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
GSK Investigational Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
GSK Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
GSK Investigational Site
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
GSK Investigational Site
City
Nantes cedex
ZIP/Postal Code
44202
Country
France
Facility Name
GSK Investigational Site
City
Nice Cedex 2
ZIP/Postal Code
06189
Country
France
Facility Name
GSK Investigational Site
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
GSK Investigational Site
City
Cremona
State/Province
Lombardia
ZIP/Postal Code
26100
Country
Italy
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
GSK Investigational Site
City
Marid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
http://clinicalstudydatarequest.com

Learn more about this trial

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

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