- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01487785
Dose-escalation, and Safety Study of LDE225 and Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer Patients
A Phase Ib, Open-label, Multicenter, Dose-escalation, Safety and Tolerability Study of LDE225 in Combination With Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
This phase Ib study includes two phases: dose escalation phase and safety expansion phase.
During the dose escalation phase, successive cohorts of eligible patients (minimum 3 and maximum 6 evaluable patients per cohort) will receive increasing oral doses of LDE225 administered on a continuous once daily (QD) dose in combination of gemcitabine. This phase of the study will determine the maximum tolerated dose (MTD) and/ or recommended dose for expansion (RDE) of LDE225 administered in combination with gemcitabine in locally advanced or metastatic pancreatic adenocarcinoma patients.
During the safety expansion phase, once the MTD of LDE225 is established, additional patients will be enrolled and treated at the MTD of LDE225 in combination with gemcitabine in order to further evaluate its safety, tolerability and explore the potential efficacy of the combined treatments on the patients in locally advanced or metastatic pancreatic adenocarcinoma.
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital Dept. of Mass General Hospital
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New York
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New York, New York, 미국, 10021
- Memorial Sloan Kettering Cancer Center MSKCC - SC
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Utah
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Salt Lake City, Utah, 미국, 84103
- University of Utah / Huntsman Cancer Institute Huntsman UT
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Catalunya
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Barcelona, Catalunya, 스페인, 08035
- Novartis Investigative Site
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Liverpool, 영국, L7 8XP
- Novartis Investigative Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with locally advanced or metastatic pancreatic adenocarcinoma that have not been previously treated or have progressed despite chemotherapy
- Performance status of 0 or 1 per WHO classification
- Adequate hematologic , renal and liver function
- Adequate blood creatine kinase value (CK < 1.5ULN)
Exclusion Criteria:
- Treatment with prior radiotherapy
- Pancreatic cancer that is potentially curable by surgery
- Women of childbearing potential unless they are using highly effective method of contraception Other protocol-defined inclusion/exclusion criteria may apply
Other protocol-defined inclusion/exclusion criteria may apply.
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: LDE225+gemcitabine
Increasing doses of LDE225 (from 400 mg) once a day + 1000 mg/m2 of gemcitabine on days 1, 8 and 15 of every 28 day cycle.
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Patients will receive increasing doses of LDE225 (from 400 mg), depending on the cohort they are assigned to, orally once daily and standard doses of gemcitabine (1000 mg/m2) on days 1, 8 and 15 of every 28-day cycle.
Patients will receive the study treatment until they progressed, experience unacceptable toxicity, withdraw from the study, or the investigator decides it is in their best interest to discontinue the study treatment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Incidence rate and category of dose limiting toxicities (DLTs)
기간: first 8 weeks of study treatment
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Dose limiting toxicities that occur during the first 8 weeks (56 days) of treatment with LDE225+gemcitabine.
Dose limiting toxicity is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that meets study specific criteria.
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first 8 weeks of study treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Incidence rate of Adverse Events and Serious Adverse Events
기간: at Informed Consent Form (ICF) sign off until 120 days after the last dose of study drug
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Adverse events and serious adverse events, changes in hematology and chemistry values and assessment of physical and neurological examinations, vital signs and electrocardiograms that occur during the reported period
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at Informed Consent Form (ICF) sign off until 120 days after the last dose of study drug
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Plasma pharmacokinetics(PK) parameters of LDE225
기간: baseline, week 9 of the study
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Area Under the Curve (AUC), Maximum observed plasma concentration after drug administration (Cmax), Time to reach Cmax (Tmax), etc.
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baseline, week 9 of the study
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Plasma pharmacokinetics (PK) of gemcitabine
기간: Baseline, week 9 of the study
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If possible: AUC, Cmax, Tmax, Half life (T1/2), Total body clearance (CL), Apparent volume of distribution at steady state (Vss)
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Baseline, week 9 of the study
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Antitumor efficacy of LDE225+gemcitabine
기간: baseline, week 9 of the study
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Efficacy endpoints (Objective response rate and progression free survival) as a function of Hh target gene expression in tumor samples
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baseline, week 9 of the study
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Progression free survival
기간: baseline, 8 weeks
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the effect of LDE225+gemcitabine on progression free survival.
Progression Free Survival is defined as the time from date of enrollment to the date of the first documented progression, or death due to any cause, or start of new anti-cancer therapy.
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baseline, 8 weeks
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Objective Response Rate
기간: Baseline, 8 weeks
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The effect of LDE225+gemcitabine on objective response rate.
Objective response rate is defined as the proportion of patients with a confirmed complete response (CR) or partial response (PR) as their best overall response per RECIST 1.0
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Baseline, 8 weeks
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Duration of Response
기간: Baseline, 8 weeks
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The effect of LDE225+gemcitabine on duration of response.
Duration of response is defined as the time from the first occurrence of complete response or partial response until the date of the first documented disease progression or death due to underlying cancer.
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Baseline, 8 weeks
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Serum tumor marker Ca 19-9
기간: On Day 1 of every cycle (cycle = 28 days)
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the effect of LDE225+gemcitabine on changes overtime in the serum tumor marker Ca 19-9 levels from baseline as assessed by central lab
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On Day 1 of every cycle (cycle = 28 days)
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공동 작업자 및 조사자
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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