A Study of Herceptin (Trastuzumab) in Patients With Metastatic or Advanced Gastric Cancer With Disease Progression
2014년 7월 23일 업데이트: Hoffmann-La Roche
An Open-label Pilot Study of Herceptin Monotherapy on Objective Treatment Response in Patients With Metastatic or Locally Advanced Gastric Cancer Who Had Disease Progression During Platinum-based or 5-fluoropyrimidine-based Chemotherapy
This study will evaluate the efficacy and safety of Herceptin in patients with metastatic or advanced gastric cancer with disease progression during platinum-based or 5-fluoropyrimidine-based chemotherapy.
The anticipated time on study treatment is until disease progression.
연구 개요
연구 유형
중재적
등록 (실제)
6
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
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 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- adult patients 18-75 years of age;
- metastatic or advanced gastric cancer;
- disease progression under or after 1 prior platinum-based or 5-fluoropyrimidine-based chemotherapy for metastatic disease;
- >=4 weeks from last platinum-based or fluoropyrimidine-based chemotherapy;
- >=1 measurable lesion;
- HER2 overexpression (IHC [2+] or [3+]).
Exclusion Criteria:
- concurrent chemotherapy or immunotherapy;
- brain or meningeal metastases;
- clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
- co-existing malignancies or malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ;
- women who are pregnant or breastfeeding.
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: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Trastuzumab Monotherapy
Initial dose of 4 milligrams (mg) per (/) kilogram (kg) by body weight (BW), followed by 2 mg/kg BW at each subsequent visit
|
4 mg/kg initial dose, followed by 2 mg/kg
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category
기간: Weekly throughout study
|
Tumor response assessed according to RECIST.
Complete response (CR): complete disappearance of all target and non-target lesions, with exception of nodal disease.
All nodes, both target and non-target, must decrease to normal (short axis less than [<]10 millimeters [mm]); no new lesions.
Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of sum of diameters of all target lesions.
Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.
Stable disease (SD): not qualifying for CR, PR, or progressive disease (PD).
Participants who could not be classified per RECIST were allocated as follows: early death from malignant disease (death due to cancer), early death because of other cause (death not related to toxicity or cancer disease), and unknown (for not fitting into the above categories).
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Weekly throughout study
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants With Clinical Benefit
기간: Weekly throughout the study
|
Participants were classified as having a clinical benefit if they had a best overall tumor response of CR, PR, or SD.
Tumor response assessed according to RECIST.
CR: complete disappearance of all target and non-target lesions, with exception of nodal disease.
All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions.
PR: ≥30% decrease under baseline of sum of diameters of all target lesions.
Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.
Stable SD: not qualifying for CR, PR, or PD.
|
Weekly throughout the study
|
|
Percentage of Participants With a Best Overall Response of CR or PR
기간: Weekly throughout the study
|
Tumor response assessed according to RECIST.
CR: complete disappearance of all target and non-target lesions, with exception of nodal disease.
All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions.
PR: ≥30% decrease under baseline of sum of diameters of all target lesions.
Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.
|
Weekly throughout the study
|
|
Overall Survival - Number of Participants Who Died
기간: Weekly throughout the study
|
OS was defined as the time, in months, from the date of study entry to the date of the death due to any cause.
If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
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Weekly throughout the study
|
|
Overall Survival
기간: Weekly throughout the study
|
Overall survival (OS) was defined as the time, in months, from the date of study entry to the date of the death due to any cause.
If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
|
Weekly throughout the study
|
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Time to Progression - Number of Participants With an Event
기간: Weekly throughout the study
|
Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause.
If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
|
Weekly throughout the study
|
|
Time to Progression
기간: Weekly throughout the study
|
Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause.
If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
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Weekly throughout the study
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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
2004년 1월 1일
기본 완료 (실제)
2008년 2월 1일
연구 완료 (실제)
2008년 2월 1일
연구 등록 날짜
최초 제출
2013년 12월 4일
QC 기준을 충족하는 최초 제출
2013년 12월 4일
처음 게시됨 (추정)
2013년 12월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 8월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 7월 23일
마지막으로 확인됨
2014년 7월 1일
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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Trastuzumab에 대한 임상 시험
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Kristina A. FanucciStemline Therapeutics, Inc.모병유방암 | 전이성 유방암 | 유방암 여성 | HER2 음성 유방암 | HER2 낮은 유방 암종미국
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Fudan University아직 모집하지 않음HER2 양성 유방암 | 뇌 전이가 있는 유방암
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Shanghai Henlius Biotech완전한