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治験 NCT04641247（対象：卵巣腫瘍、乳腺腫瘍）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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グラクソ・スミスクラインA Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study 第II相・フェーズ2 30
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT04641247 は 卵巣腫瘍、乳腺腫瘍 に関する 治療 の研究で、第II相・フェーズ2 介入研究 臨床試験 です。現在は 募集中 で、2021年4月16日 から開始しています。30 名の参加者 の募集が計画されています。この試験は グラクソ・スミスクライン によって主導され、2026年11月13日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月29日 です。
概要
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.
公式タイトル
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
疾患名
卵巣腫瘍乳腺腫瘍その他の研究識別子
- 213409
- 2020-002667-53 (EudraCT番号)
- 2023-506618-29 (登録識別子) (CTIS)
NCT番号
開始日
2021-04-16
最終更新日
2025-09-29
終了予定日
2026-11-13
目標参加者数
30
試験の種類
介入研究
治験の相・段階
第II相・フェーズ2
状況
募集中
キーワード
Adverse events
Open-label extension
Parent study
Niraparib
Safety
Open-label extension
Parent study
Niraparib
Safety
主目的
治療
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的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 i...もっと見る | Niraparib Niraparib tablets or capsules will be given once a day via the oral route. |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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. | Up to 5 years |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- 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.
- 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).
グラクソ・スミスクライン254 件のアクティブな治験を探索試験中央連絡先
連絡先: US GSK Clinical Trials Call Center, 877-379-3718, [email protected]
連絡先: EU GSK Clinical Trials Call Center, +44 (0) 20 89904466, [email protected]
25 8カ国の場所
Arizona
GSK Investigational Site, Tucson, Arizona, 85710, United States
完了
California
GSK Investigational Site, Encinitas, California, 92024, United States
US GSK Clinical Trials Call Center, 連絡先, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, 連絡先, +44 (0) 20 8990 4466, [email protected]
Alberto Bessudo, 主任研究者
募集中
GSK Investigational Site, Los Angeles, California, 90048, United States
US GSK Clinical Trials Call Center, 連絡先, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, 連絡先, +44 (0) 20 8990 4466, [email protected]
Bobbie Rimel, 主任研究者
募集中
GSK Investigational Site, Whittier, California, 90603, United States
完了
Florida
GSK Investigational Site, Jacksonville, Florida, 32224, United States
完了
Georgia
GSK Investigational Site, Atlanta, Georgia, 30342, United States
US GSK Clinical Trials Call Center, 連絡先, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, 連絡先, +44 (0) 20 8990 4466, [email protected]
Meaghan Tenney, 主任研究者
募集中
Illinois
GSK Investigational Site, Harvey, Illinois, 60426, United States
US GSK Clinical Trials Call Center, 連絡先, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, 連絡先, +44 (0) 20 8990 4466, [email protected]
Ivy Abraham, 主任研究者
募集中
Massachusetts
GSK Investigational Site, Boston, Massachusetts, 02115, United States
US GSK Clinical Trials Call Center, 連絡先, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, 連絡先, +44 (0) 20 8990 4466, [email protected]
Wendy Y Chen, 主任研究者
募集中
Michigan
GSK Investigational Site, Grand Rapids, Michigan, 60637-1470, United States
US GSK Clinical Trials Call Center, 連絡先, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, 連絡先, +44 (0) 20 8990 4466, [email protected]
Manish Sharma, 主任研究者
募集中
New Jersey
GSK Investigational Site, Morristown, New Jersey, 07962-1956, United States
US GSK Clinical Trials Call Center, 連絡先, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, 連絡先, +44 (0) 20 8990 4466, [email protected]
Nana Eleonore Tchabo, 主任研究者
募集中
New York
GSK Investigational Site, Lake Success, New York, 11042, United States
US GSK Clinical Trials Call Center, 連絡先, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, 連絡先, +44 (0) 20 8990 4466, [email protected]
Veena John, 主任研究者
募集中
North Carolina
GSK Investigational Site, Charlotte, North Carolina, 28204, United States
US GSK Clinical Trials Call Center, 連絡先, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, 連絡先, +44 (0) 20 8990 4466, [email protected]
Antoinette Tan, 主任研究者
募集中
Ohio
GSK Investigational Site, Cleveland, Ohio, 44195, United States
完了
GSK Investigational Site, Graz, A-8036, Austria
US GSK Clinical Trials Call Center, 連絡先, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, 連絡先, +44 (0) 20 8990 4466, [email protected]
Edgar Petru, 主任研究者
募集中
GSK Investigational Site, Vienna, 1090, Austria
US GSK Clinical Trials Call Center, 連絡先, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, 連絡先, +44 (0) 20 8990 4466, [email protected]
Stephan Polterauer, 主任研究者
募集中
British Columbia
GSK Investigational Site, Kelowna, British Columbia, V5Z 4E6, Canada
US GSK Clinical Trials Call Center, 連絡先, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, 連絡先, +44 (0) 20 8990 4466, [email protected]
Anna Tinker, 主任研究者
募集中
Ontario
GSK Investigational Site, Toronto, Ontario, M5G 2M9, Canada
US GSK Clinical Trials Call Center, 連絡先, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, 連絡先, +44 (0) 20 8990 4466, [email protected]
Amit M. Oza, 主任研究者
募集中
Quebec
GSK Investigational Site, Montreal, Quebec, H4A 3J1, Canada
US GSK Clinical Trials Call Center, 連絡先, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, 連絡先, +44 (0) 20 8990 4466, [email protected]
Lucy Gilbert, 主任研究者
募集中
GSK Investigational Site, Odense C, 5000, Denmark
完了
GSK Investigational Site, Nantes, 44202, France
US GSK Clinical Trials Call Center, 連絡先, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, 連絡先, +44 (0) 20 8990 4466, [email protected]
Alain Lortholary, 主任研究者
募集中
GSK Investigational Site, Nice, 06189, France
完了
GSK Investigational Site, Haifa, 3109601, Israel
US GSK Clinical Trials Call Center, 連絡先, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, 連絡先, +44 (0) 20 8990 4466, [email protected]
Emad Matanes, 主任研究者
募集中
GSK Investigational Site, Cremona, 26100, Italy
US GSK Clinical Trials Call Center, 連絡先, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, 連絡先, +44 (0) 20 8990 4466, [email protected]
Daniele Generali, 主任研究者
募集中
GSK Investigational Site, Madrid, 28040, Spain
US GSK Clinical Trials Call Center, 連絡先, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, 連絡先, +44 (0) 20 8990 4466, [email protected]
Antonio Casado Herráez, 主任研究者
募集中
GSK Investigational Site, Madrid, 28046, Spain
US GSK Clinical Trials Call Center, 連絡先, 877-379-3718, [email protected]
EU GSK Clinical Trials Call Centre, 連絡先, +44 (0) 20 8990 4466, [email protected]
Andrés Redondo Sánchez, 主任研究者
募集中