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Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC) (GRANITE-1)

2015년 10월 8일 업데이트: Novartis Pharmaceuticals

A Randomized, Double-blind, Multi-center Phase III Study Comparing Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Gastric Cancer After Progression on 1 or 2 Prior Systemic Chemotherapy

This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

656

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 네덜란드
      • Amsterdam, 네덜란드, 1105 AZ
        • Novartis Investigative Site
  • 뉴질랜드
      • Auckland, 뉴질랜드
        • Novartis Investigative Site
  • 대만
      • Liouying Township, 대만
        • Novartis Investigative Site
      • Niaosong Township, 대만, 83301
        • Novartis Investigative Site
      • Taipei, 대만, 10048
        • Novartis Investigative Site
      • Taipei, 대만
        • Novartis Investigative Site
    • Taoyuan/ Taiwan ROC
      • Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, 대만, 33305
        • Novartis Investigative Site
  • 대한민국
      • Seoul, 대한민국, 136-705
        • Novartis Investigative Site
      • Taegu, 대한민국, 700 - 721
        • Novartis Investigative Site
    • Jeollabuk-do
      • Jeonju-si, Jeollabuk-do, 대한민국, 561-712
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, 대한민국, 05505
        • Novartis Investigative Site
      • Seoul, Korea, 대한민국, 06351
        • Novartis Investigative Site
      • Seoul, Korea, 대한민국, 110 744
        • Novartis Investigative Site
      • Seoul, Korea, 대한민국, 03722
        • Novartis Investigative Site
  • 독일
      • Berlin, 독일, 13353
        • Novartis Investigative Site
      • Bielefeld, 독일, 33604
        • Novartis Investigative Site
      • Frankfurt, 독일, 60488
        • Novartis Investigative Site
      • Mainz, 독일, 55131
        • Novartis Investigative Site
      • München, 독일, 81675
        • Novartis Investigative Site
      • Offenburg, 독일, 77652
        • Novartis Investigative Site
      • Trier, 독일, 54290
        • Novartis Investigative Site
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, 독일, 68305
        • Novartis Investigative Site
  • 러시아 연방
      • Moscow, 러시아 연방, 115478
        • Novartis Investigative Site
      • St. Petersburg, 러시아 연방, 197758
        • Novartis Investigative Site
  • 멕시코
    • Distrito Federal
      • México, Distrito Federal, 멕시코, 14080
        • Novartis Investigative Site
    • Guanajuato
      • León, Guanajuato, 멕시코, 37000
        • Novartis Investigative Site
  • 미국
    • Arkansas
      • Fayetteville, Arkansas, 미국, 72703
        • Highlands Oncology Group DeptofHighlandsOncologyGrp(2)
    • California
      • Redlands, California, 미국, 92374
        • Loma Linda Oncology Medical Group Loma Linda
    • Michigan
      • Detroit, Michigan, 미국, 48202-2689
        • Henry Ford Hospital Dept. of Henry Ford Hospital
    • Minnesota
      • Minneapolis, Minnesota, 미국, 55455
        • University of Minnesota Cancer Center
    • Texas
      • Dallas, Texas, 미국, 75390-8527
        • University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(4)
      • Fort Worth, Texas, 미국, 76104
        • The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2)
      • Houston, Texas, 미국, 77030-4009
        • University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
    • Washington
      • Seattle, Washington, 미국, 98109-1023
        • University of Washington Cancer Care Seattle Cancer Alliance
  • 벨기에
      • Charleroi, 벨기에, 6000
        • Novartis Investigative Site
      • Gent, 벨기에, 9000
        • Novartis Investigative Site
      • Leuven, 벨기에, 3000
        • Novartis Investigative Site
      • Liege, 벨기에, 4000
        • Novartis Investigative Site
  • 스페인
    • Catalunya
      • Barcelona, Catalunya, 스페인, 08035
        • Novartis Investigative Site
  • 아르헨티나
      • Buenos Aires, 아르헨티나, C1264AAA
        • Novartis Investigative Site
      • Cordoba, 아르헨티나, X5000IUG
        • Novartis Investigative Site
    • Viedma
      • Rio Negro, Viedma, 아르헨티나, 8500
        • Novartis Investigative Site
  • 영국
      • East Yorkshire, 영국, HU16 5JQ
        • Novartis Investigative Site
      • London, 영국, SW3 6JJ
        • Novartis Investigative Site
      • London, 영국, WC1E 6HX
        • Novartis Investigative Site
      • Manchester, 영국, M20 4BX
        • Novartis Investigative Site
      • Wolverhampton, 영국, WV10 0QP
        • Novartis Investigative Site
    • Middlesex
      • Northwood, Middlesex, 영국, HA6 2RN
        • Novartis Investigative Site
    • Surrey
      • Sutton, Surrey, 영국, SM2 5PT
        • Novartis Investigative Site
  • 이스라엘
      • Jerusalem, 이스라엘, 9112001
        • Novartis Investigative Site
      • Petach Tikva, 이스라엘, 49100
        • Novartis Investigative Site
      • Ramat Gan, 이스라엘, 5266202
        • Novartis Investigative Site
      • Rehovot, 이스라엘, 76100
        • Novartis Investigative Site
  • 이탈리아
      • Frattamaggiore, 이탈리아, 80020
        • Novartis Investigative Site
    • FI
      • Firenze, FI, 이탈리아, 50134
        • Novartis Investigative Site
    • MI
      • Rozzano, MI, 이탈리아, 20089
        • Novartis Investigative Site
    • MO
      • Modena, MO, 이탈리아, 41100
        • Novartis Investigative Site
    • PN
      • Aviano, PN, 이탈리아, 33081
        • Novartis Investigative Site
  • 일본
    • Aichi
      • Nagoya, Aichi, 일본, 464-8681
        • Novartis Investigative Site
    • Chiba
      • Kashiwa, Chiba, 일본, 277-8577
        • Novartis Investigative Site
    • Ehime
      • Matsuyama, Ehime, 일본, 791-0280
        • Novartis Investigative Site
    • Fukuoka
      • Fukuoka-city, Fukuoka, 일본, 812-8582
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo-city, Hokkaido, 일본, 060-8648
        • Novartis Investigative Site
    • Kanagawa
      • Sagamihara, Kanagawa, 일본, 252-0380
        • Novartis Investigative Site
    • Miyagi
      • Sendai-city, Miyagi, 일본, 980-8574
        • Novartis Investigative Site
    • Osaka
      • OsakaSayama, Osaka, 일본, 589-8511
        • Novartis Investigative Site
      • Takatsuki-city, Osaka, 일본, 569-8686
        • Novartis Investigative Site
    • Saitama
      • Kitaadachi-gun, Saitama, 일본, 362-0806
        • Novartis Investigative Site
    • Tochigi
      • Utsunomiya, Tochigi, 일본, 320-0834
        • Novartis Investigative Site
    • Tokyo
      • Chuo-ku, Tokyo, 일본, 104-0045
        • Novartis Investigative Site
      • Koto, Tokyo, 일본, 135-8550
        • Novartis Investigative Site
      • Mitaka-city, Tokyo, 일본, 181-8611
        • Novartis Investigative Site
  • 중국
      • Beijing, 중국, 100039
        • Novartis Investigative Site
      • Beijing, 중국, 100036
        • Novartis Investigative Site
      • Guangzhou, 중국, 510060
        • Novartis Investigative Site
      • Shanghai, 중국, 200032
        • Novartis Investigative Site
      • Shanghai, 중국, 200003
        • Novartis Investigative Site
      • Shanghai, 중국, 200025
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, 중국, 510515
        • Novartis Investigative Site
    • Hebei
      • Shijiazhuang, Hebei, 중국, 050011
        • Novartis Investigative Site
    • Heilongjiang
      • Harbin, Heilongjiang, 중국, 150081
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, 중국, 210002
        • Novartis Investigative Site
      • Suzhou, Jiangsu, 중국, 215006
        • Novartis Investigative Site
    • Liaoning
      • Shenyang, Liaoning, 중국
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, 중국, 610041
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, 중국, 310016
        • Novartis Investigative Site
  • 캐나다
    • British Columbia
      • North Vancouver, British Columbia, 캐나다, V7L 2L7
        • Novartis Investigative Site
      • Vancouver, British Columbia, 캐나다, V5Z 4E6
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, 캐나다, M4N 3M5
        • Novartis Investigative Site
      • Toronto, Ontario, 캐나다, M5B 1W8
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, 캐나다, H3G 1A4
        • Novartis Investigative Site
      • Sherbrooke, Quebec, 캐나다, J1H 5N4
        • Novartis Investigative Site
  • 태국
      • Bangkok, 태국, 10700
        • Novartis Investigative Site
      • Bangkok, 태국, 10400
        • Novartis Investigative Site
      • Songkla, 태국, 90110
        • Novartis Investigative Site
  • 페루
    • Lima
      • San Borja, Lima, 페루, 41
        • Novartis Investigative Site
      • San Isidro, Lima, 페루, 27
        • Novartis Investigative Site
  • 프랑스
      • Avignon Cedex, 프랑스, 84082
        • Novartis Investigative Site
      • Clermont Ferrand cedex 1, 프랑스, 63003
        • Novartis Investigative Site
      • Clichy, 프랑스, 92110
        • Novartis Investigative Site
      • Dijon, 프랑스, 21079
        • Novartis Investigative Site
      • Lyon Cedex 08, 프랑스, 69373
        • Novartis Investigative Site
      • Marseille cedex 05, 프랑스, 13385
        • Novartis Investigative Site
      • Montpellier Cedex 5, 프랑스, 34298
        • Novartis Investigative Site
      • Nice Cedex 2, 프랑스, 06189
        • Novartis Investigative Site
      • Paris, 프랑스, 75015
        • Novartis Investigative Site
      • Pessac Cedex, 프랑스, 33604
        • Novartis Investigative Site
      • Poitiers, 프랑스, 86000
        • Novartis Investigative Site
      • Reims, 프랑스, 51092
        • Novartis Investigative Site
      • Rennes Cedex, 프랑스, 35062
        • Novartis Investigative Site
      • Toulouse Cedex 4, 프랑스, 31054
        • Novartis Investigative Site
      • Villejuif Cedex, 프랑스, 94805
        • Novartis Investigative Site
  • 호주
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, 호주, 2605
        • Novartis Investigative Site
    • Queensland
      • Herston, Queensland, 호주, 4029
        • Novartis Investigative Site
    • South Australia
      • Kurralta Park, South Australia, 호주, 5037
        • Novartis Investigative Site
      • North Adelaide, South Australia, 호주, 5006
        • Novartis Investigative Site
    • Victoria
      • Box Hill, Victoria, 호주, 3128
        • Novartis Investigative Site
      • Clayton, Victoria, 호주, 3168
        • Novartis Investigative Site
      • Footscray, Victoria, 호주, 3011
        • Novartis Investigative Site
      • Heidelberg, Victoria, 호주, 3084
        • Novartis Investigative Site
      • Prahran, Victoria, 호주, 3181
        • Novartis Investigative Site
  • 홍콩
      • Hong Kong SAR, 홍콩
        • Novartis Investigative Site

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:

  • Male or female patients > 18 years old
  • Histologically or cytologically confirmed and documented gastric adenocarcinoma
  • Documented progression after 1 or 2 prior chemotherapy treatments for advanced disease
  • ECOG Performance Status of < 2
  • Lab parameters within specifically defined intervals
  • Able to provide written informed consent

Exclusion Criteria:

  • Patients who have received > 2 prior systemic therapies for advanced disease
  • Administration of another anticancer therapy within 3 weeks prior to randomization
  • Chronic treatment with steroids or another immunosuppressive agent
  • Major surgery within 2 weeks prior to randomization
  • Patients with CNS metastases
  • Any other severe and/or uncontrolled medical condition

Other protocol-defined inclusion/exclusion criteria may apply

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: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Everolimus + BSC
All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
의약품: Everolimus
Everolimus was formulated as tablets of 5 mg strength. In both treatment arms, the study drug was given by continuous oral daily dosing of 10 mg (2 tablets x 5 mg) each morning.
다른 이름들:
  • RAD001
의약품: Best Supportive Care (BSC)
Best supportive care is defined as care in accordance with the local practice of an individual institution or center, specifically excluding anti-cancer treatments.
위약 비교기: Placebo + BSC
All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
의약품: Best Supportive Care (BSC)
Best supportive care is defined as care in accordance with the local practice of an individual institution or center, specifically excluding anti-cancer treatments.
의약품: Everolimus placebo
Placebo was formulated to be indistinguishable from the everolimus tablets, also formulated as tablets of 5 mg strength. In both treatment arms, the study drug was given by continuous oral daily dosing of 10 mg (2 tablets x 5 mg) each morning.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Overall Survival (OS)
기간: 2.5 years
The primary objective of this study was to compare OS between everolimus + best supportive care (BSC) and placebo + BSC. OS, was defined as the time from date of randomization to the date of death due to any cause. If at the analysis cut-off date a patient was not known to have died, survival was censored at the date of the last contact. OS was analyzed using the Kaplan Meier estimates method.
2.5 years

2차 결과 측정

결과 측정
측정값 설명
기간
Progression Free Survival (PFS)
기간: 2.5 years
Progression free survival was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause, where progression was based on Investigator assessment of baseline and post-baseline scans according to RECIST. Progression free survival was censored if no PFS event was observed before the first to occur out of (i) the cut-off date, or (ii) the date when a further anticancer therapy was started. The censoring date was the date of the last adequate tumor assessment before either of these two events occurred. If a PFS event was observed after two or more missing or non-evaluable tumor assessments, then the date of progression was censored at the date of the last adequate tumor assessment; for a PFS event observed after a single missing or non-evaluable tumor assessment, the actual date of disease progression was used. Anslsis was done using Kaplan-Meier estimates method.
2.5 years
Patient Reported Outcome (PRO): Time to Definitive Deterioration of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Scores
기간: 2.5 years
The EORTC QLQ-C30 global health status/quality of life sub-scale (QL) was pre-specified as the primary domain of interest, followed by physical functioning (PF), social functioning (SF) and emotional functioning (EF).The EORTC QLQ-C30 questionnaire, along with a module specific for gastric cancer patients (EORTC QLQ-STO22), was used to evaluate PRO. The QLQ-C30 has five function scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and a global health status/quality of life scale. In addition, there are questions that assess specific symptoms. The QLQ-STO22 consists of 22 questions that make up five multi-item scales (dysphagia, pain, reflux, eating and anxiety) and four single-item scales (dry mouth, tasting, body image and hair loss).
2.5 years
Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
기간: 2.5 years
The ECOG PS scale was used to classify patients according to their functional impairment, with scores ranging from 0 (fully active) to 5 (dead). An analysis of the time to definitive deterioration of the ECOG PS by one category of the score from baseline was performed. Definitive deterioration was defined as a definitive increase by one category from baseline in ECOG PS, with no later improvements observed during the course of the study. A single measure reporting an increase in ECOG PS is sufficient to consider it as a definitive worsening only if it was the last one available for the patient. Kaplan-Meier method was used to estimate the distribution function of time to definitive worsening.
2.5 years
Overall Response Rate (ORR)
기간: 2.5 years
ORR was defined as the proportion of patients with measurable disease in whom best overall response (OR) was either complete response (CR) or partial response (PR) according to RECIST criteria.
2.5 years
Everolimus Steady State Concentraions at Predose (Cmin) and Cmax at Week 5
기간: Week 5
Cmin is the minimum (trough) steady-state drug concentration in the blood during multiple dosing and Cmax is the maximum (peak) blood drug concentration after dose administration. Cmax is estimated as the maximum of C1h and C2H. C1h is 1 hour post-dose blood concentration and C2h is 2 hour post-dose blood concentration. Only valid pre-dose (Cmin), C1h, and C2h everolimus samples were included in the analysis. Valid pre-dose samples were confirmed blood samples collected at steady-state, collected immediately prior to dosing on the same study day, and collected at approximately 24 ± 4 hours after the previous dose and with no vomiting within the first 4 hours following the last dose. Valid C1h and C2h samples were confirmed blood samples collected at steady-state and within ± 1 hour window and with no vomiting within the first 4 hours following the current and previous dose.
Week 5
Everolimus Steady State Concentraions at Predose (Cmin) and Cmax by Region Asia vs. Rest of the World (ROW) at Week 5
기간: Week 5
Cmin is the minimum (trough) steady-state drug concentration in the blood during multiple dosing and Cmax is the maximum (peak) blood drug concentration after dose administration. Cmax is estimated as the maximum of C1h and C2H. C1h is 1 hour post-dose blood concentration and C2h is 2 hour post-dose blood concentration. Only valid pre-dose (Cmin), C1h, and C2h everolimus samples were included in the analysis. Valid pre-dose samples were confirmed blood samples collected at steady-state, collected immediately prior to dosing on the same study day, and collected at approximately 24 ± 4 hours after the previous dose and with no vomiting within the first 4 hours following the last dose. Valid C1h and C2h samples were confirmed blood samples collected at steady-state and within ± 1 hour window and with no vomiting within the first 4 hours following the current and previous dose.
Week 5

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Novartis Pharmaceuticals

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

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

2009년 7월 1일

기본 완료 (실제)

2014년 1월 1일

연구 완료 (실제)

2014년 1월 1일

연구 등록 날짜

최초 제출

2009년 4월 8일

QC 기준을 충족하는 최초 제출

2009년 4월 9일

처음 게시됨 (추정)

2009년 4월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 10월 8일

마지막으로 확인됨

2015년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CRAD001R2301
  • 2008-006544-20 (EudraCT 번호)

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. .

진행성 위암에 대한 임상 시험

Everolimus에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Sri Lanka

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다