- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00521404
Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer
2021년 3월 11일 업데이트: Daiichi Sankyo, Inc.
Phase 2 Multicenter, Open-Label Study of CS-1008, A Humanized Monoclonal Antibody Targeting Death Receptor 5 (DR5), In Combination With Gemcitabine in Chemotherapy Naive Subjects With Unresectable or Metastatic Pancreatic Cancer
Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to subjects with previously untreated and unresectable (unable to be surgically removed) or metastatic (spread to other areas beyond the pancreas) pancreatic cancer.
연구 개요
상세 설명
Primary Objective:
- To evaluate the efficacy of CS-1008 administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer, based on the progression-free survival at 16 weeks.
Secondary Objectives:
- To evaluate the efficacy of CS-1008 administered in combination with gemcitabine on overall progression-free survival rate, objective response rate, duration of response, and overall survival.
- To determine the pharmacokinetics of BIP CS-1008 and DSC CS-1008.
- To study potential biomarkers of CS-1008 activity
- To assess possible human anti-human antibody formation after exposure to CS-1008
- To evaluate the safety profile of CS-1008 when administered in combination with gemcitabine to chemotherapy naive subjects with unresectable or metastatic pancreatic cancer.
연구 유형
중재적
등록 (실제)
65
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Birmingham, Alabama, 미국
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District of Columbia
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Washington, District of Columbia, 미국
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Florida
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Fort Myers, Florida, 미국
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Georgia
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Atlanta, Georgia, 미국
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Tucker, Georgia, 미국, 30084
- Georgia Cancer Specialists
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Illinois
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Decatur, Illinois, 미국
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Minnesota
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Minneapolis, Minnesota, 미국
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Ohio
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Cincinnati, Ohio, 미국
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Tennessee
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Chattanooga, Tennessee, 미국
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Nashville, Tennessee, 미국
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Texas
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Temple, Texas, 미국
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Virginia
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Richmond, Virginia, 미국
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Histologically or cytologically confirmed resectable or metastatic pancreatic cancer; not previously treated with chemotherapy; measurable disease; 18 years of age or older
Exclusion Criteria:
- Anticipation of need for major surgery or radiation therapy during the study
- Heart Disease exclusions: myocardial infarction or unstable angina within the past 6 months; severe or unstable angina pectoris within the past 6 months; coronary or peripheral artery bypass graft within the past 6 mo., etc.
- Clinically significant active infection or history of HIV
- Partial or complete bowel obstruction
- Poorly controlled psychiatric illness
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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: CS-1008 + gemcitabine
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CS-1008: 8mg/kg loading dose followed by 3mg/kg weekly.
다른 이름들:
Gemcitabine - 1000mg/meter sq
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Progression-Free Survival Rate at 16 Weeks Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
기간: Baseline to the date of disease progression or death due to any cause (whichever occurs first), up to 16 weeks post dose.
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Progression-free survival rate (PFS) was defined as the time from the date of the first administration of the study drug (Day 1) to the date of the first objective documentation of disease progression or death resulting from any cause, whichever came first at 16 weeks post-treatment with CS-1008.
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Baseline to the date of disease progression or death due to any cause (whichever occurs first), up to 16 weeks post dose.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Kaplan-Meier (Non-Parametric) Analysis of Progression-Free Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
기간: Baseline up to date of disease progression or death due to any cause (whichever occurs first), up to approximately 36 months post dose.
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PFS (Progression-free survival) was defined as the time from the date of the first administration of study drug (Day 1) to the date of the first objective documentation of disease progression or death resulting from any cause, whichever came first.
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Baseline up to date of disease progression or death due to any cause (whichever occurs first), up to approximately 36 months post dose.
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Overall Survival Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
기간: Baseline to death due to any cause, up to approximately 36 months post dose.
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OS (Overall Survival) was defined as the time from the date of the first administration of study drug (Day 1) to the date of death.
If there was no death reported for a subject before the cut-off date for overall survival analysis, overall survival was censored at the last contact date at which the subject was known to be alive.
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Baseline to death due to any cause, up to approximately 36 months post dose.
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Best Overall Tumor Response Following Treatment With CS-1008 in Combination With Gemcitabine in Chemotherapy-Naïve Participants With Unresectable or Metastatic Pancreatic Cancer
기간: Baseline to up to date of first documented objective response or disease progression (whichever occurs first), up to approximately 36 months post dose.
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The best overall response the best response (in the order of confirmed complete response [CR], confirmed partial response [PR], unconfirmed CR, unconfirmed PR, stable disease [SD], and progressive disease[PD]) among all overall responses recorded from the start of treatment until the subject withdrew from the study.
If there was no tumor assessment after the first infusion of study drug and no clinical disease progression recorded, the best overall response was classified as Unknown.
CR was defined as the disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, PD was defined as at least a 20% increase in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease PD according to RECIST guideline (version 1.1).
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Baseline to up to date of first documented objective response or disease progression (whichever occurs first), up to approximately 36 months post dose.
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Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to CS-1008 Experienced by ≥5% of Participants by System Organ Class and Preferred Term
기간: Baseline up to 30 days post last dose, up to approximately 36 months post dose.
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A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that: emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment or worsens in severity during treatment relative to the pre-treatment state when the AE was continuous.
The AEs with an onset date on Day 1 (the date on which the first dose of study medication was administered) were counted as a TEAE.
An AE that occurred more than 30 days after the last dose of study medication was not included as a TEAE unless it was considered drug-related.
A TEAE was considered related to CS-1008 or gemcitabine if the investigator considered the event as possibly, probably, or definitely related to treatment, or if the investigator's assessment of the relationship was unknown.
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Baseline up to 30 days post last dose, up to approximately 36 months post dose.
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Number of Participants With Treatment-Emergent Adverse Events Considered by the Investigator at Least Possibly Related to Gemcitabine Experienced by ≥5% of Participants by System Organ Class and Preferred Term
기간: Baseline up to 30 days post last dose, up to approximately 36 months post dose.
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A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that: emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment or worsens in severity during treatment relative to the pre-treatment state when the AE was continuous.
The AEs with an onset date on Day 1 (the date on which the first dose of study medication was administered) were counted as a TEAE.
An AE that occurred more than 30 days after the last dose of study medication was not included as a TEAE unless it was considered drug-related.
A TEAE was considered related to CS-1008 or gemcitabine if the investigator considered the event as possibly, probably, or definitely related to treatment, or if the investigator's assessment of the relationship was unknown.
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Baseline up to 30 days post last dose, up to approximately 36 months post dose.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2007년 8월 15일
기본 완료 (실제)
2010년 8월 20일
연구 완료 (실제)
2010년 8월 20일
연구 등록 날짜
최초 제출
2007년 8월 24일
QC 기준을 충족하는 최초 제출
2007년 8월 24일
처음 게시됨 (추정)
2007년 8월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 4월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 3월 11일
마지막으로 확인됨
2021년 3월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CS1008-A-U201
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니
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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