- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01938638
Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer
An Open-label Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY1143572 Given in a Once-daily or an Intermittent Dosing Schedule in Subjects With Advanced Malignancies
The purpose of this study Part A is to determine the safety, tolerability and the pharmacokinetics of BAY1143572 in subjects with advanced malignancies, which are either refractory to or ineligible for treatment with standard agents.
The purpose of this study Part B is:
Determine the safety, tolerability, pharmacokinetics (PK) and maximum tolerated dose (MTDG-CSF) of BAY1143572 with concurrent administration of the granulocyte colony-stimulating factors (G-CSF) in an intermittent and continuous dosing schedule in subjects with advanced malignancies.
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Taipei, 대만, 10002
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Seoul, 대한민국, 110-744
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Seoul, 대한민국, 120-752
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Seoul, 대한민국, 05505
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Arkansas
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Fayetteville, Arkansas, 미국, 72703
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Massachusetts
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Boston, Massachusetts, 미국, 02215
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Michigan
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Ann Arbor, Michigan, 미국, 48109
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New Jersey
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Hackensack, New Jersey, 미국, 07601
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New York
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New York, New York, 미국, 10032
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South Carolina
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Charleston, South Carolina, 미국, 29425
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Singapore, 싱가포르, 119228
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Singapore, 싱가포르, 169610
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or female subjects aged >/=21 years
- Dose escalation phase: Subjects with histologically or cytologically confirmed advanced malignancies (solid tumors and malignant lymphomas) who were refractory to or had exhausted all available therapies. Subjects had to have evaluable or measurable disease (as per RECIST 1.1 or Cheson 2007 criteria).
- Expansion phase only: Subjects with advanced, histologically or cytologically confirmed gastric cancer, triple negative breast cancer (TNBC), or diffuse large B-cell lymphoma (DLBCL), who were refractory to or had exhausted all available therapies. Subjects had to have evaluable or measurable disease (as per RECIST 1.1 or Cheson 2007 criteria).
- Archival tumor tissue to conduct molecular and / or genetic studies must be collected from all study subjects enrolled in this study.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 12 weeks
- Adequate bone marrow, liver, and renal functions as assessed by laboratory analysis to be conducted within 7 days prior to the first dose of study drug
- International normalized ratio (INR) and partial thromboplastin time (PTT) </=1.5 times ULN (upper limit of normal)
Exclusion Criteria:
- Known hypersensitivity to the study drug or excipients of the preparation or any agent given in association with this study
- History of cardiac disease including congestive heart failure > New York Heart Association (NYHA) Class II, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months) or myocardial infarction within the past 6 months and cardiac arrhythmias requiring anti-arrhythmic therapy except for beta-blockers and digoxin; evidence for uncontrolled coronary artery disease (e.g. angina pectoris, myocardial infarction within 6 months prior to study entry, major regional wall motion abnormalities upon baseline echocardiography)
- Previous pulmonary embolism within 12 months prior to study entry
- Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg on 2 or more consecutive blood pressure readings, despite optimal medical management
- Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C
- Known history of human immunodeficiency virus (HIV) infection
- Chronic or active hepatitis B or C, requiring antiviral therapy
- Active clinically serious infections of > Grade 2 and/or active infections that require treatment with systemic agent
- Uncontrolled seizure disorder requiring therapy (such as steroids or anti-epileptics with significant CYP interaction)
- Evidence or history of bleeding disorder, i.e. any hemorrhage / bleeding event of > Grade 2 within 4 weeks prior to the first dose of study drug
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: BAY1143572 [continuous]
BAY1143572 will be administered from cycle 1, day 1 (C1D1) onwards once daily continuously
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실험적: BAY1143572 [on/off]
BAY1143572 will be administered from C1D1 in a 3 days on/4 days off schedule
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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안전성 및 내약성의 척도로서 부작용이 있는 참가자 수
기간: 최대 2년
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최대 2년
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Maximum tolerated dose (MTD) of BAY1143572
기간: Up to 1 year
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In Part A: Maximum tolerated dose (MTD) of BAY1143572 In Part B; Maximum tolerated dose ( MTD) with G-CSF of BAY114357 The MTD is defined as the highest dose that can be given such that not more than 20% of subjects experience a dose limiting toxicity (DLT) during cycle 1.
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Up to 1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Maximum total drug concentration (Cmax)
기간: Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
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Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
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Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24)
기간: Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
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Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
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Area under the plasma concentration-time curve from time zero to infinity (AUC)
기간: Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
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Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
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Time of maximum observed concentration (tmax)
기간: Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
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Cycle 1, Day 1 and Day 15 (each cycle is 28 days)
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Tumor response based on RECIST 1.1 or Cheson 2007 criteria
기간: Up to 100 weeks
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Up to 100 weeks
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Biomarker evaluation by determination of MYC protein expression and PCNA mRNA
기간: Cycle 1, Day 1, Day 8 and Day 15 (each cycle is 28 days)
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PCNA: proliferating cell nuclear Antigen mRNA: messenger ribonucleic acid
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Cycle 1, Day 1, Day 8 and Day 15 (each cycle is 28 days)
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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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