Safety, Efficacy and Pharmacokinetic of BPI-9016M in Patients With c-Met- Dysregulated Advanced NSCLC
Safety, Efficacy and Pharmacokinetic of BPI-9016M in Patients With c-Met- Dysregulated Advanced NSCLC: A Phase Ib Study,Open-label,Dose-expansion Study
調査の概要
詳細な説明
This study was a multicenter, open, single-arm, Ib-stage expanded clinical study.
Part I：On the basis of Ia-stage dose escalation study, a safe and effective dose of -300 mg, 450 mg, 600 mg and 800 mg was selected to enlarge the enrollment study in patients with c-Met-dysregulated advanced NSCLC, and continuously administered until the disease progressed or could not be tolerated, in order to further evaluate the safety, ttolerability, efficacy and pharmacokinetics of BPI-9016M.
Part II：On the basis of the completed research results of Ia stage and part I, a safe and effective dose of 400 mg twice a day (bid) was selected to conduct an expanded enrollment study in NSCLC patients with MET exon 14 skipping alterations, and continuously administered until the disease progressed or could not be tolerated, in order to further evaluate the safety, ttolerability, efficacy and pharmacokinetics of BPI-9016M.
研究の種類
入学 (予想される)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Yuankai Shi, MD
- メール：syuankai@yahoo.cn
研究場所
-
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Anhui
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Hefei、Anhui、中国、230601
- 募集
- The Second Affiliated Hospital of Anhui Medical University
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コンタクト：
- Hui Zhao, MD
-
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Beijing
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Beijing、Beijing、中国、100032
- 募集
- Peking Union Medical College Hospital
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コンタクト：
- Mengzhao Wang, MD
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Beijing、Beijing、中国、100142
- 募集
- Beijing Cancer Hospital
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コンタクト：
- Ziping Wang, MD
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Beijing、Beijing、中国、100021
- 募集
- Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences
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コンタクト：
- Yuankai Shi, MD
- メール：syuankaipumc@126.com
-
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Hebei
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Shijiazhuang、Hebei、中国、050011
- まだ募集していません
- Fourth Hospital of Hebei Medical University
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主任研究者：
- Mingxia Wang
-
主任研究者：
- Da Jiang, MD
-
-
Heilongjiang
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Harbin、Heilongjiang、中国、150081
- まだ募集していません
- Affiliated Cancer Hospital of Harbin Medical University
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コンタクト：
- Yan Yu, MD
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Liaoning
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Shenyang、Liaoning、中国、110001
- 募集
- The First Hospital of China Medical University
-
コンタクト：
- Yunpeng Liu, MD
-
-
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
説明
Inclusion Criteria:
- Histologically or cytologically confirmed, locally advanced or metastatic NSCLC patients, who is not suitable for surgery or radiotherapy
- Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST1.1)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy ≥12 weeks
- Must have evidence of positive c-Met protein expression by IHC from either local data or the results of molecular pre-screening evaluations；Must haved evidence of MET exon 14 skipping alterations in blood and/or tissue samples.
- Adequate bone marrow, hepatic, and renal function
- Patients of child bearing potential must agree to take contraception during the study and for 3 months after the last day of treatment
- Signed Informed Consent Form
Exclusion Criteria:
- Prior or current treatment with the type II of c-MET inhibitor or HGF/c-Met antibody therapy
- Confirmed ALK or ROS1 rearrangement
- Prior treatment with targeting agents (Including EGFR tyrosine kinase inhibitors,VEGFR TKIs,the tpye I of MET TKIs, etc.) within 14 days or 5 half-life
- Prior treatment with anticancer agents (Including cytotoxic chemotherapy,radiotherapy, immunotherapy etc.) within 4 weeks
- Brain/meninges metastases unless asymptomatic, stable and not requiring steroids for maintenance
- History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease, radiological documentation of idiopathic pulmonary fibrosis at baseline; uncontrolled pleural effusion/pericardial effusion
- Any evidence of severe or uncontrolled systemic diseases, including CTCAE 2 or higher active infection, unstable angina pectoris, congestive cardiac failure and severe liver/renal or metabolic disease
- Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
- History of organ transplant; had surgery or severe injury within 4 weeks
- Uncontrolled hypertension（Systolic blood pressure≥160mmHg and/or diastolic blood pressure≥100mmHg ）
- Patients unable to swallow orally administered medication, prior surgical procedures affecting absorption.
- Pregnant (positive pregnancy test) or lactating women
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 |
|---|---|
|
実験的：BPI-9016M
Part I：Four dose cohorts will be evaluated, including 300mg, 450mg, 600mg, 800mg. BPI-9016M Tablet will be administered orally to patients once daily for each dose cohort. Part II：400mg BPI-9016M Tablet will be administered orally to patients twice a day. |
Part I：Four dose cohorts will be evaluated, including 300mg, 450mg, 600mg, 800mg. BPI-9016M Tablet will be administered orally to patients once daily for each dose cohort. Part II：400mg BPI-9016M Tablet will be administered orally to patients twice a day.
他の名前：
|
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 |
|---|---|
|
Participants with Adverse Events
時間枠：18 months
|
18 months
|
|
Objective Response Rate
時間枠：16 weeks
|
16 weeks
|
|
Disease Control Rate
時間枠：16 weeks
|
16 weeks
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
全生存
時間枠：24ヶ月
|
24ヶ月
|
|
無増悪生存
時間枠：18ヶ月
|
18ヶ月
|
|
AUCss
時間枠：4 weeks
|
4 weeks
|
|
Css-min
時間枠：18 months
|
18 months
|
協力者と研究者
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 (見積もり)
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
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