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
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Yuankai Shi, MD
- 이메일: syuankai@yahoo.cn
연구 장소
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Anhui
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Hefei, Anhui, 중국, 230601
- 모병
- The Second Affiliated Hospital of Anhui Medical University
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연락하다:
- Hui Zhao, MD
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Beijing
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Beijing, Beijing, 중국, 100032
- 모병
- Peking Union Medical College Hospital
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연락하다:
- Mengzhao Wang, MD
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Beijing, Beijing, 중국, 100142
- 모병
- Beijing Cancer Hospital
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연락하다:
- Ziping Wang, MD
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Beijing, Beijing, 중국, 100021
- 모병
- Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences
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연락하다:
- Yuankai Shi, MD
- 이메일: syuankaipumc@126.com
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Hebei
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Shijiazhuang, Hebei, 중국, 050011
- 아직 모집하지 않음
- Fourth Hospital of Hebei Medical University
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수석 연구원:
- Mingxia Wang
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수석 연구원:
- Da Jiang, MD
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Heilongjiang
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Harbin, Heilongjiang, 중국, 150081
- 아직 모집하지 않음
- Affiliated Cancer Hospital of Harbin Medical University
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연락하다:
- Yan Yu, MD
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Liaoning
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Shenyang, Liaoning, 중국, 110001
- 모병
- The First Hospital of China Medical University
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연락하다:
- Yunpeng Liu, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Participants with Adverse Events
기간: 18 months
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18 months
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Objective Response Rate
기간: 16 weeks
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16 weeks
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Disease Control Rate
기간: 16 weeks
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16 weeks
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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전반적인 생존
기간: 24개월
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24개월
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무진행 생존
기간: 18개월
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18개월
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AUCss
기간: 4 weeks
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4 weeks
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Css-min
기간: 18 months
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18 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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