Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety. (EPIK-RO)
An Open Label, Multi-center Alpelisib Roll-over Study to Assess Long-term Safety in Participants Who Have Completed a Novartis Sponsored Alpelisib (BYL719) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Alpelisib.
調査の概要
状態
条件
詳細な説明
Eligible participants are those who are receiving alpelisib, either as a single agent or in combination with other drugs, at the end of one of the following parent studies: CBYL719F12401 (NCT04980833), CBYL719G12301 (NCT04208178), CBYL719C2303 (NCT05038735), CBYL719C1201 (NCT04524000), CBYL719C2201 (NCT04544189), or CLEE011X2107 (NCT01872260).
Participants transition directly from the parent study into this roll-over study without a separate screening period. At enrollment, participants continue treatment with the same combination and the same dose that were administered at the end of the parent study. Study visits, treatment administration, and safety assessments generally follow the schedules used in the parent study.
Participants continue receiving alpelisib until clinical benefit is no longer observed, study treatment is discontinued for safety or other protocol-defined reasons, or another discontinuation criterion is met. Clinical benefit is evaluated by the investigator at scheduled visits.
Safety is monitored throughout the study through the collection of adverse events and serious adverse events. Safety assessments are conducted at regular intervals during treatment in accordance with the study protocol and local clinical practice.
At discontinuation of study treatment, participants complete an end-of-treatment visit. All participants are followed for safety for 30 days after the last dose of alpelisib.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Novartis Pharmaceuticals
- 電話番号：+41613241111
- メール：novartis.email@novartis.com
研究連絡先のバックアップ
- 名前：Novartis Pharmaceuticals
- 電話番号：+81337978748
- メール：novartis.email@novartis.com
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Key Inclusion Criteria:
- Written informed consent/assent, according to local guidelines, signed by the participants and/or by the parents or legal guardian prior to enrolling in the roll-over study.
- Participant currently enrolled in a Novartis-sponsored study, is currently receiving alpelisib as a single agent or in combination with other drugs, and has fulfilled all on-treatment requirements in the parent study.
- Participant is currently benefiting from the treatment with alpelisib as determined by the Investigator in the parent study.
- Participant demonstrated compliance with the visit schedule in the parent study, and in the opinion of the Investigator has shown willingness and ability to comply with future visit schedules, treatment plans, and any other study procedures in this protocol.
Key Exclusion Criteria:
- Participant had permanently discontinued from alpelisib in the parent study for any reason including withdrawal of consent.
- Participant currently has ongoing/unresolved treatment related Grade 3 or higher AEs, and/or any ongoing/unresolved AE or toxicities for which alpelisib dosing has been interrupted in the parent study. Participants meeting all other eligibility criteria may be enrolled once toxicities have improved to allow alpelisib dosing to resume as stated in the parent protocol.
- Participant's ongoing treatment is currently approved and reimbursed for their indication at their country level. In exceptional cases where the treatment is reimbursed at the country level, but not individual level, please contact the Novartis Study Team.
- Concurrent participation in any other investigational clinical trial other than the parent study.
- Pregnant or nursing (breastfeeding) women.
- Female participants of childbearing potential who do not consent to use a highly effective method of contraception, and male participants who do not consent to use a condom and/or a highly effective method of contraception, including refraining from sperm donation and complying with measures to prevent exposure of a partner to alpelisib via seminal fluid, for the duration of the study and for one week following discontinuation of alpelisib (or longer if required per parent protocol).
Other inclusion/exclusion criteria may apply.
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
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Alpelisib (BYL719) or in Combination Therapy
Eligible participants will continue treatment with the same combination and dose as in the parent study until end of treatment (EOT), followed by a 30-day safety follow-up.
|
Administered as oral tablets at dose levels as per the parent study, taken once daily.
他の名前：
Administered as an intramuscular injection at dose levels and dosing schedule as per standard of care, in accordance with the parent study.
Administered as an intravenous infusion of a reconstituted lyophilized powder at dose levels as per the parent study, given every 21 days.
Administered as an intravenous infusion of a solution concentrate at dose levels as per the parent study, given every 21 days.
Administered as oral tablets at a dose of 2.5 mg, taken once daily, as per the parent study.
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 53 months
|
Incidence of adverse events by type, frequency, and severity, as graded by the NCI CTCAE version 4.03.
|
From start of treatment up to 30 days after last dose of study treatment, assessed up to approximately 53 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of participants with Clinical Benefit Rate (CBR)
時間枠：Up to approximately 54 months
|
Clinical benefit is defined as the investigator's assessment that the participant continues to derive benefit from alpelisib treatment, based on overall clinical evaluation at scheduled visits, and that continued treatment is appropriate.
|
Up to approximately 54 months
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Novartis Pharmaceuticals、Novartis Pharmaceuticals
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
追加の関連 MeSH 用語
- 部位別新生物
- 新生物
- 皮膚疾患
- 乳房の病気
- 皮膚および結合組織疾患
- 乳房腫瘍
- ホルモン
- ホルモン、ホルモン代替品、ホルモン拮抗薬
- アミノ酸、ペプチド、およびタンパク質
- タンパク質
- 有機化学物質
- 複素環化化合物、1リング
- 複素環化化合物
- アゾール
- 多環式化合物
- 抗体、モノクローナル、ヒト化
- 抗体、モノクローナル
- 抗体
- 免疫グロブリン
- 免疫タンパク質
- 血液タンパク質
- 血清グロブリン
- グロブリン
- ステロイド
- 融合リング化合物
- ニトリル
- エストラジオール
- Estrenes
- エストラン
- エストラジオール同族体
- ゴナダルステロイドホルモン
- ゴナダルホルモン
- トリアゾール
- トラスツズマブ
- レトロゾール
- フルベストラント
- ペルズマブ
- アルペリシブ
その他の研究ID番号
- CBYL719F12003B
- 2026-525890-38-00 (レジストリ識別子：EU CT Number)
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
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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
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。