- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00121680
A Phase I/Ib, Multicenter, Open-Label, Dose Escalation Study of E7080 in Patients With Solid Tumors and in Combination With Temozolomide in Patients With Advanced and/or Metastatic Melanoma
The purpose of this study is to study the safety of E7080 administered to patients with solid tumors or lymphomas.
Please note: this study is now recruiting patients with advanced and/or metastatic melanoma only.
In the current phase of this study, To determine the MTD and the pharmacokinetic profile of E7080 when given as continuous daily (qd) dosing in combination with temozolomide.
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Texas
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Dallas, Texas, 미국
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Houston, Texas, 미국
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Patients with a histologically and/or cytologically confirmed solid tumor or lymphoma who are resistant/refractory to approved therapies or for whom no curative therapies are available All previous treatment (including surgery and radiotherapy) must have been completed at least four weeks prior to study entry and any acute toxicities must have resolved Aged 18 years. Because of the potential additional risk to children suggested by preclinical models of dysplasia in growing epiphyseal growth plates, enrollment will be limited to adult patients ECOG performance status score of 0 or 1 Written informed consent prior to any study specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice Willing and able to comply with the protocol guidelines for the duration of the study For patients in the Schedule 2 Expanded Melanoma Cohort only: histologically and/or cytologically confirmed advanced and/or metastatic melanoma who are resistant/refractory to approved therapies or for whom no curative therapies are available. In addition, patients must have melanoma lesions amenable to tissue biopsy and must agree to undergo biopsies of malignant and adjacent non-malignant tissue pretreatment and at the end of Cycle 1 of treatment For patients in the Melanoma Combination Cohort only: histologically and/or cytologically confirmed melanoma that is advanced and/or metastatic
Exclusion Criteria:
Untreated or unstable metastases to the central nervous system (CNS) tumors. Patients who have completed local therapy and have discontinued the use of steroids for this indication at least 4 weeks prior to commencing treatment and in whom stability has been proven by at least 2 CT or MRI scans obtained at least 4 weeks apart are permitted Any of the following laboratory parameters: hemoglobin < 9 g/dL (5.6 mmol/L); neutrophils <1.5 x 109/L; platelets <100 x 109/L; serum bilirubin >25 mol/L (1.5 mg/dL); liver function tests with values >3 x upper limit of normal (ULN); renal function with serum creatinine >1.5 ULN or creatinine clearance < 60 mL/min Positive history of HIV, active hepatitis B or active hepatitis C or severe/uncontrolled intercurrent illness or infection Patients with centrally located non-small cell lung cancers and squamous cell lung cancers Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start Patients with marked Baseline prolongation of QT/QTc interval (QTc interval > 450 msec for males or > 470 msec for females) using the Fridericia method for QTc analysis Bleeding or thrombotic disorders, or using therapeutic dosages of anticoagulants, such as warfarin. Occasional use of NSAIDs and antiplatelet agents such as aspirin, clopidogrel, aggrenox and dipyridamole are not considered exclusionary if taken <7 days per 28 days. However, if the patient requires chronic use (>/=7 days out of 28 days) of full doses of aspirin or NSAIDs then the patient is excluded. Concomitant antiplatelet agents and NSAIDs should be used with caution Requirement for chronic use of full dose aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) Poorly controlled hypertension (defined as requiring changes in any hypertensive regimen within 1 week three months of study entry) or patients diagnosed with hypertension based on repeat blood pressure measurements of >160/90 mmHg at Screening >1+ proteinuria on urine dipstick testing or 30 mg/dL A history of gastrointestinal malabsorption or having undergone surgery requiring gastrointestinal anastomoses within four weeks of starting therapy or who have not recovered from major surgery within three weeks of starting therapy History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the Investigator, would impair study compliance Any treatment with investigational drugs within 30 days before the start of the study Previous treatment with E7080 Known intolerance to temozolomide (or any of the excipients) Women who are pregnant or breast-feeding; women of childbearing potential with a positive pregnancy test at Screening or no pregnancy test. Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception (including two forms of contraception, one of which must be a barrier method) in the opinion of the Investigator (revised per Amendment 04). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential Fertile males with female partners who are not willing to use contraception or whose female partners are not using adequate contraceptive protection Legal incapacity
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: 1
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Oral.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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To determine the maximum tolerated dose (MTD) of E7080 for two different schedules incorporating dose interruptions.
기간: Every two cycles.
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Every two cycles.
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2차 결과 측정
결과 측정 |
기간 |
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Identify the dose limiting toxicities (DLT); explore safety and tolerability; determine pharmacokinetic profile; explore anti-tumor efficacy.
기간: Every two cycles.
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Every two cycles.
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Eisai Inc., Eisai Limited
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- E7080-A001-102
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
E7080에 대한 임상 시험
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Mayo ClinicNational Cancer Institute (NCI)완전한
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Emory UniversityNational Cancer Institute (NCI); Eisai Co., Ltd.모병절제 불가능한 간세포 암종 | 재발성 간세포 암종 | III기 간세포 암종 AJCC v8 | IIIA기 간세포 암종 AJCC v8 | IV기 간세포 암종 AJCC v8 | IVA기 간세포 암종 AJCC v8 | IVB기 간세포 암종 AJCC v8 | IIIB기 간세포 암종 AJCC v8미국
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Emory UniversityEisai Inc.종료됨
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Eisai Co., Ltd.완전한
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Eisai Inc.완전한
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Humanity & Health Medical Group LimitedBeijing 302 Hospital; Kindai University Faculty of Medicine종료됨
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Eisai Inc.완전한4기 흑색종 | 절제 불가능한 3기미국, 영국, 호주, 독일
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M.D. Anderson Cancer Center모병재발성 원발성 복막 고등급 장액성 선암종 | 고등급 난소 장액성 선암종 | 재발성 고급 나팔관 장액성 선암종 | 재발성 고등급 난소 장액성 선암종 | 고급 나팔관 장액성 선암종 | 복막 고등급 장액성 선암종미국
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Eisai Inc.완전한