A Study for Post-Marketing Surveillance of Niraparib in the Treatment of Adult Participants for Approved Indications in South Korea
Post-Marketing Surveillance (Usage Results Study) of Niraparib in the Treatment of Adult Patients for Approved Indications in South Korea
調査の概要
状態
条件
詳細な説明
This is a long-term prospective, observational post-marketing surveillance study of niraparib in participants with ovarian cancer (including fallopian tube, or primary peritoneal cancer) who are in complete or partial response to first-line platinum-based chemotherapy or who had complete or partial response to 2 or more lines of platinum-based chemotherapy or who have been treated with 3 or more prior chemotherapy regimens with either: BRCA mutation irrespective of platinum sensitivity; or platinum-sensitive HRD positive. The study will assess the safety and effectiveness of niraparib for its approved indication with real-world setting in South Korea.
The study will enroll approximately 600 participants. The data will be collected prospectively at the study sites will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:
• Participants With Ovarian Cancer
The multi-center study will be conducted in South Korea. Data collection will be based on routinely scheduled and emergency visits during a 24-month surveillance period or until end of the study whichever occurs first after drug administration. The overall duration of the study will be approximately 6 years.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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-
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Busan、大韓民国、48108
- 募集
- Inje University Haeundae Paik Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Monotherapy for the maintenance treatment of adult participants with ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
- Monotherapy for the maintenance treatment of adult participants with recurrent high-grade serous ovarian cancer (including fallopian tube, or primary peritoneal cancer) who are in a complete or partial response to 2 or more lines of platinum-based chemotherapy.
- Monotherapy treatment of adult participants with recurrent ovarian, fallopian tube or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens with either a) BRCA mutation (irrespective of platinum sensitivity) or b) platinum-sensitive HRD positive.
Exclusion Criteria:
- Treated with niraparib outside of the locally approved label in Korea.
- Niraparib is contraindicated as per product label.
- Participating in other clinical trials of cancer treatment.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:コホート
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
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Participants with Ovarian Cancer
Participants diagnosed with ovarian cancer (including fallopian tube or primary peritoneal cancer) who have been prescribed with niraparib for the first time in a real-world setting, and who are in a complete or partial response to first-line platinum-based chemotherapy or who had complete or partial response to 2 or more line of platinum-based chemotherapy or who have been treated with 3 or more prior chemotherapy regimens with either breast cancer susceptibility gene (BRCA) mutation (irrespective of platinum sensitivity) or platinum-sensitive homologous recombination deficiency (HRD) positive will be observed prospectively over 24-month period, or until treatment discontinuation, or until end of study, which occurs first.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Percentage of Participants with AEs, SAEs, and AESIs
時間枠:Baseline up to 24 months
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Baseline up to 24 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Time-to-Treatment Discontinuation (TTD)
時間枠:From the date of first dose administration until discontinuation or death due to any cause whichever occurs first (up to 24 months)
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TTD is defined as the time interval from the date of initiation of treatment until discontinuation of treatment, or death due to any cause, whichever occurs first.
Participants who have not discontinued treatment, or died, will be censored at the last known time that the participant was on treatment.
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From the date of first dose administration until discontinuation or death due to any cause whichever occurs first (up to 24 months)
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Progression Free Survival (PFS)
時間枠:From the date of first dose administration until disease progression or death due to any cause whichever occurs first (up to 24 months)
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PFS is defined as the time interval from the date of initiation of treatment until objectively documented disease progression, or death due to any cause, whichever occurs first.
Participants who do not have disease progression, or have not died, will be censored at the last known time that the participant was progression-free.
Progressive disease (PD) is defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
The determination of disease progression will be at the Investigators discretion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
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From the date of first dose administration until disease progression or death due to any cause whichever occurs first (up to 24 months)
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- Niraparib-5001
- U1111-1257-0180 (レジストリ識別子:WHO)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- 研究プロトコル
- 統計分析計画 (SAP)
- インフォームド コンセント フォーム (ICF)
- 臨床試験報告書(CSR)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。