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Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

2018년 8월 15일 업데이트: Bayer

A Double-Blind Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Eligible subjects were randomized 1:1 to sorafenib 800 mg daily or matching placebo. Progression was assessed every 8 weeks by modified RECIST criteria. Subjects had the option to unblind study treatment after progression and to receive open label sorafenib regardless of initial treatment assignment. Following discontinuation of study treatment, subjects were followed for survival every 3 months in long-term follow-up. Subjects who terminated study treatment (either double only or double blind and open label) for reasons other than death, lost to follow-up or consent withdrawn entered long-term follow up

연구 유형

중재적

등록 (실제)

417

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 네덜란드
      • Groningen, 네덜란드, 9713 GZ
      • Leiden, 네덜란드, 2333 ZA
  • 대한민국
      • Daejeon, 대한민국, 301-721
      • Seoul, 대한민국, 137-701
      • Seoul, 대한민국, 110-744
      • Seoul, 대한민국, 120-752
      • Seoul, 대한민국, 135-710
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, 대한민국, 138-736
        • Asan Medical Center
  • 덴마크
      • Odense C, 덴마크, 5000
  • 독일
    • Bayern
      • Erlangen, Bayern, 독일, 91054
      • München, Bayern, 독일, 81377
      • Würzburg, Bayern, 독일, 97080
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, 독일, 45122
      • Köln, Nordrhein-Westfalen, 독일, 50924
    • Sachsen
      • Leipzig, Sachsen, 독일, 04103
  • 러시아 연방
      • Obninsk, 러시아 연방, 249036
  • 미국
    • California
      • Los Angeles, California, 미국, 90048
      • Stanford, California, 미국, 94305-5820
    • Connecticut
      • New Haven, Connecticut, 미국, 06520
    • Georgia
      • Atlanta, Georgia, 미국, 30322
    • Massachusetts
      • Boston, Massachusetts, 미국, 02118
    • Michigan
      • Ann Arbor, Michigan, 미국, 48109
    • Missouri
      • Saint Louis, Missouri, 미국, 63110
    • New Mexico
      • Albuquerque, New Mexico, 미국, 87106
    • New York
      • New York, New York, 미국, 10029
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
      • Pittsburgh, Pennsylvania, 미국, 15213-1863
    • Texas
      • Houston, Texas, 미국, 77030
    • Washington
      • Seattle, Washington, 미국, 98109-1023
  • 벨기에
      • Bruxelles - Brussel, 벨기에, 1000
  • 불가리아
      • Sofia, 불가리아, 1527
  • 사우디 아라비아
      • Riyadh, 사우디 아라비아, 11211
  • 스웨덴
      • Göteborg, 스웨덴, 413 45
      • Linköping, 스웨덴, 581 85
      • Lund, 스웨덴, 221 85
      • Stockholm, 스웨덴, 171 76
  • 스페인
      • Barcelona, 스페인, 08035
    • Madrid
      • Majadahonda, Madrid, 스페인, 28222
  • 영국
      • Cardiff, 영국, CF14 2TL
      • Glasgow, 영국, G12 0YN
      • Leeds, 영국, LS9 7TF
      • London, 영국, SE1 9RT
      • London, 영국, SM2 5PT
      • Manchester, 영국, M20 4BX
      • Newcastle Upon Tyne, 영국, NE7 7DN
      • Sutton, 영국, SM2 5PT
    • Aberdeenshire
      • Aberdeen, Aberdeenshire, 영국, AB25 2ZN
  • 오스트리아
      • Wien, 오스트리아, 1090
  • 이탈리아
    • Campania
      • Napoli, Campania, 이탈리아, 80131
    • Liguria
      • Genova, Liguria, 이탈리아, 16132
    • Lombardia
      • Milano, Lombardia, 이탈리아, 20133
      • Milano, Lombardia, 이탈리아, 20122
      • Milano, Lombardia, 이탈리아, 20162
    • Sicilia
      • Catania, Sicilia, 이탈리아, 95029
    • Toscana
      • Pisa, Toscana, 이탈리아, 56124
      • Siena, Toscana, 이탈리아, 53100
    • Umbria
      • Perugia, Umbria, 이탈리아, 06126
  • 일본
    • Aichi
      • Nagoya, Aichi, 일본, 466-8560
      • Nagoya, Aichi, 일본, 464-8681
    • Chiba
      • Kashiwa, Chiba, 일본, 277-8577
    • Tokyo
      • Koto-ku, Tokyo, 일본, 135-8550
  • 중국
      • Beijing, 중국, 100730
      • Beijing, 중국, 100021
      • Chengdu, 중국, 610041
      • Hangzhou, 중국, 310022
      • Shanghai, 중국, 200127
      • Shanghai, 중국, 200030
      • Tianjin, 중국, 300060
    • Guangdong
      • Guangzhou, Guangdong, 중국, 510060
  • 폴란드
      • Gliwice, 폴란드, 44-101
      • Poznan, 폴란드, 60-355
      • Warszawa, 폴란드, 02-781
      • Warszawa, 폴란드, 04-141
  • 프랑스
      • Angers, 프랑스, 49933
      • Bordeaux, 프랑스, 33076
      • Caen, 프랑스, 14076
      • LILLE cedex, 프랑스, 59037
      • Lyon, 프랑스, 69373
      • MARSEILLE cedex, 프랑스, 13273
      • Paris, 프랑스, 75651
      • Villejuif, 프랑스, 94805

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:

  • Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular and Hurthle cell)
  • Poorly differentiated and other thyroid variants (e.g. insular, tall cell, etc.) are eligible provided that the histology has no medullary differentiation nor anaplastic features
  • Progression within 14 months (RECIST [Response Evaluation Criteria in Solid Tumors] should be used as a basis for the assessment of disease progression)
  • RAI (radioactive iodine) refractory

Exclusion Criteria:

  • Histologic subtypes of thyroid cancer other than differentiated (i.e. like anaplastic and medullary carcinoma, lymphoma or sarcoma)
  • Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies (licensed or investigational) that target VEGF (vascular endothelial growth factor) or VEGF Receptors or other targeted agents
  • Prior anti-cancer treatment for thyroid cancer with use of chemotherapy (low dose chemotherapy for radiosensitization is allowed) or Thalidomide or any of its derivatives

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: Sorafenib (Nexavar, BAY43-9006)
Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
의약품: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg will be administered orally, twice daily (approximately every 12 hours).
위약 비교기: Placebo
Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
의약품: Placebo
Placebo (2 tablets) will be administered orally, twice daily (approximately every 12 hours).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation
기간: Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years
PFS=time from randomization to first observed disease progression (radiological according to central assessment or clinical due to bone irradiation, whichever is earlier), or death due to any cause, if death occurred before progression. Progression was assessed by RECIST criteria, version 1.0, modified for bone lesions. PFS for participants without disease progression or death at the time of analysis or unblinding were censored at the last date of tumor assessment before unblinding. Participants with no tumor evaluation after baseline were censored at Day 1. PD (Progression Disease)=At least a 20% increase in sum of longest diameters (LD) of measured lesions taking as reference the smallest sum LD on study since the treatment started or the appearance of 1 or more new lesions. New lesions also constituted PD. In exceptional circumstances, unequivocal progression of a nonmeasured lesion may have been accepted as evidence of disease progression in participants with measurable disease.
Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Survival (OS)
기간: From randomization of the first subject until the database cut-off (30 AUG 2017), study duration approximately eight years
Overall survival was defined as the time (days) from date of randomization to date of death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Since the median value could not be estimated due to censored data, the percentage of participants who died is presented.
From randomization of the first subject until the database cut-off (30 AUG 2017), study duration approximately eight years
Time to Progression (TTP) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation
기간: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Time to progression was defined at the time (days) from randomization to progression (based on central assessment [radiological and clinical progression due to bone irradiation])
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Disease Control Rate (DCR) Based on Central Assessment
기간: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Disease control rate was defined as the proportion of subjects whose best response was complete response (CR), partial response (PR), or stable disease (SD). Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, CR and PR were to be confirmed by another scan at least 4 weeks later; SD had to be documented at least 4 weeks after date of randomization. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum. SD = steady state of disease which is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Response Rate Based on Central Assessment
기간: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Response rate was defined as the proportion of subjects whose best response was CR or PR. Per RECIST, CR and PR was to be confirmed by another scan at least 4 weeks later. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Duration of Response (DOR) Based on Central Assessment
기간: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum.
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Maximum Percent Reduction in Target Lesion Size Based on Central Assessment
기간: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
The magnitude of change from baseline in target lesion size in evaluable participants with scans was determined.
From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
AUC(0-12h),ss (Area Under the Concentration Time Curve From Time 0 to 12 Hours at Steady State)
기간: A single pharmacokinetic plasma sample was collected at steady state (after 14 days of uninterrupted, unmodified sorafenib dosing)
Sorafenib AUC(0-12h),ss (area under the concentration time curve from time 0 to 12 hours at steady state) was estimated from the steady state plasma concentration.
A single pharmacokinetic plasma sample was collected at steady state (after 14 days of uninterrupted, unmodified sorafenib dosing)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Bayer

협력자

Amgen

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 (실제)

2009년 10월 15일

기본 완료 (실제)

2012년 8월 31일

연구 완료 (실제)

2017년 8월 30일

연구 등록 날짜

최초 제출

2009년 9월 24일

QC 기준을 충족하는 최초 제출

2009년 9월 24일

처음 게시됨 (추정)

2009년 9월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 9월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 8월 15일

마지막으로 확인됨

2018년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 14295 (기타 식별자: City of Hope Medical Center)
  • 2009-012007-25 (EudraCT 번호)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

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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