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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002667-53 | EudraCT Number | ||
| 2023-506618-29 | Registry Identifier | CTIS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving niraparib | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niraparib | Drug | Niraparib tablets or capsules will be given once a day via the oral route. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) | AEs, SAEs and AESI will be collected. | Up to 5 years |
| 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. | Up to 5 years |
| 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. | Up to 5 years |
| Number of participants with clinically significant changes in vital signs | Number of participants with clinically significant changes in vital signs will be assessed. | Up to 5 years |
| Number of participants with clinically significant changes in physical examination | Number of participants with clinically significant changes in physical examination will be assessed. | Up to 5 years |
| Number of participants with use of concomitant medications | Number of participants using concomitant medications will be assessed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Completed | Tucson | Arizona | 85710 | United States | |
| GSK Investigational Site |
GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf.
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Participants will receive niraparib once a day, continuously throughout each 90-day cycle.
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This will be an open-label study.
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| Up to 5 years |
| Recruiting |
| Encinitas |
| California |
| 92024 |
| United States |
|
| GSK Investigational Site | Recruiting | Los Angeles | California | 90048 | United States |
|
| GSK Investigational Site | Completed | Whittier | California | 90603 | United States |
| GSK Investigational Site | Completed | Jacksonville | Florida | 32224 | United States |
| GSK Investigational Site | Recruiting | Atlanta | Georgia | 30342 | United States |
|
| GSK Investigational Site | Recruiting | Harvey | Illinois | 60426 | United States |
|
| GSK Investigational Site | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| GSK Investigational Site | Recruiting | Grand Rapids | Michigan | 60637-1470 | United States |
|
| GSK Investigational Site | Recruiting | Morristown | New Jersey | 07962-1956 | United States |
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| GSK Investigational Site | Recruiting | Lake Success | New York | 11042 | United States |
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| GSK Investigational Site | Recruiting | Charlotte | North Carolina | 28204 | United States |
|
| GSK Investigational Site | Completed | Cleveland | Ohio | 44195 | United States |
| GSK Investigational Site | Recruiting | Graz | A-8036 | Austria |
|
| GSK Investigational Site | Recruiting | Vienna | 1090 | Austria |
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| GSK Investigational Site | Recruiting | Kelowna | British Columbia | V5Z 4E6 | Canada |
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| GSK Investigational Site | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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| GSK Investigational Site | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
|
| GSK Investigational Site | Completed | Odense C | 5000 | Denmark |
| GSK Investigational Site | Completed | Nantes | 44202 | France |
| GSK Investigational Site | Completed | Nice | 06189 | France |
| GSK Investigational Site | Recruiting | Haifa | 3109601 | Israel |
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| GSK Investigational Site | Recruiting | Cremona | 26100 | Italy |
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| GSK Investigational Site | Recruiting | Madrid | 28040 | Spain |
|
| GSK Investigational Site | Recruiting | Madrid | 28046 | Spain |
|
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C545685 | niraparib |
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