GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma
2018년 3월 9일 업데이트: GlaxoSmithKline
A Phase III Randomized, Open-label Study Comparing GSK1120212 to Chemotherapy in Subjects With Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma
This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma.
All subjects must have a BRAF mutation-positive tumour sample.
Subjects who have received up to one prior regimen of chemotherapy in the advanced or metastatic melanoma setting will be enrolled into the study.
Subjects with any prior BRAF or MEK inhibitor use will be excluded.
Approximately 297 subjects will be enrolled with 2:1 randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy arm).
The primary endpoint for the statistical analysis will be a comparison of progression free survival for subjects receiving GSK1120212 compared to chemotherapy.
Subjects who have progression on chemotherapy will be offered the option to receive GSK1120212.
연구 개요
연구 유형
중재적
등록 (실제)
322
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Athens, 그리스, 11527
- GSK Investigational Site
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Athens, 그리스, 185 47
- GSK Investigational Site
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Thessaloniki, 그리스, 564 29
- GSK Investigational Site
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Oslo, 노르웨이, 0310
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Christchurch, 뉴질랜드, 8011
- GSK Investigational Site
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Dunedin, 뉴질랜드, 9016
- GSK Investigational Site
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Newtown, Wellington, 뉴질랜드, 6002
- GSK Investigational Site
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Berlin, 독일, 10117
- GSK Investigational Site
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Baden-Wuerttemberg
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Heidelberg, Baden-Wuerttemberg, 독일, 69120
- GSK Investigational Site
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Mannheim, Baden-Wuerttemberg, 독일, 68167
- GSK Investigational Site
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Tuebingen, Baden-Wuerttemberg, 독일, 72076
- GSK Investigational Site
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Bayern
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Muenchen, Bayern, 독일, 80804
- GSK Investigational Site
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Wuerzburg, Bayern, 독일, 97080
- GSK Investigational Site
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Niedersachsen
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Buxtehude, Niedersachsen, 독일, 21614
- GSK Investigational Site
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Nordrhein-Westfalen
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Essen, Nordrhein-Westfalen, 독일, 45122
- GSK Investigational Site
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Sachsen
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Dresden, Sachsen, 독일, 01307
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Schleswig-Holstein
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Luebeck, Schleswig-Holstein, 독일, 23538
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Chelyabinsk, 러시아 연방, 454087
- GSK Investigational Site
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Magnitogorsk, 러시아 연방, 455001
- GSK Investigational Site
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Moscow, 러시아 연방, 115478
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St. Petersburg, 러시아 연방, 197758
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Arizona
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Tucson, Arizona, 미국, 85724-5024
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Florida
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Fort Myers, Florida, 미국, 33916
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Georgia
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Athens, Georgia, 미국, 30607
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Marietta, Georgia, 미국, 30060
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Iowa
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Iowa City, Iowa, 미국, 52242
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Louisiana
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Metairie, Louisiana, 미국, 70006
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Massachusetts
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Boston, Massachusetts, 미국, 02114
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New Jersey
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Morristown, New Jersey, 미국, 07962-1956
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Ohio
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Columbus, Ohio, 미국, 43210
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South Carolina
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Columbia, South Carolina, 미국, 29210
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Tennessee
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Chattanooga, Tennessee, 미국, 37404
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Memphis, Tennessee, 미국, 38120
- GSK Investigational Site
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Nashville, Tennessee, 미국, 37203
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Brussels, 벨기에, 1200
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Charleroi, 벨기에, 6000
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Gent, 벨기에, 9000
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Jette, 벨기에, 1090
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Kortrijk, 벨기에, 8500
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Leuven, 벨기에, 3000
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Wilrijk, 벨기에, 2610
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Yvoir, 벨기에, 5530
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Goteborg, 스웨덴, SE-413 45
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Linkoping, 스웨덴, SE-581 85
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Lund, 스웨덴, SE-221 85
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Stockholm, 스웨덴, SE-171 76
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Uppsala, 스웨덴, SE-751 85
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Zurich, 스위스, 8091
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Ciudad Autonoma de Buenos Aires, 아르헨티나, C1121ABE
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Aberdeen, 영국, AB25 2ZN
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Birmingham, 영국, B15 2TH
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Chelmsford, 영국, CM1 7ET
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Leeds, 영국, LS9 7TF
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London, 영국, SW3 6JJ
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London, 영국, W1G 6AD
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Manchester, 영국, M20 4BX
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Oxford, 영국, OX3 7LJ
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Southampton, 영국, SO16 6YD
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Cambridgeshire
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Cambridge, Cambridgeshire, 영국, CB2 2QQ
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Middlesex
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Northwood, Middlesex, 영국, HA6 2RN
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Surrey
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Sutton, Surrey, 영국, SM2 5PT
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Graz, 오스트리아, 8036
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Wien, 오스트리아, 1090
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Dnepropetrovsk, 우크라이나, 49102
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Kharkiv, 우크라이나, 61070
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Kyiv, 우크라이나, 03022
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Kyiv, 우크라이나, 03115
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Lviv, 우크라이나, 79031
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Sumy, 우크라이나, 40005
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Sympheropol, 우크라이나, 95023
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Ternopil, 우크라이나, 46023
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Uzhgorod, 우크라이나, 88017
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Lombardia
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Milano, Lombardia, 이탈리아, 20132
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Milano, Lombardia, 이탈리아, 20133
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Milano, Lombardia, 이탈리아, 20141
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Toscana
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Pisa, Toscana, 이탈리아, 56126
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Hradec Kralove, 체코, 500 05
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Ostrava, 체코, 708 52
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Praha 2, 체코, 128 08
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Zlin, 체코, 76275
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Alberta
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Calgary, Alberta, 캐나다, T2N 4N2
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British Columbia
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Vancouver, British Columbia, 캐나다, V5Z 4E6
- GSK Investigational Site
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3H 2Y9
- GSK Investigational Site
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Ontario
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Hamilton, Ontario, 캐나다, L8V 5C2
- GSK Investigational Site
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London, Ontario, 캐나다, N6A 4L6
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Oshawa, Ontario, 캐나다, L1G 2B9
- GSK Investigational Site
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Ottawa, Ontario, 캐나다, K1H 8L6
- GSK Investigational Site
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Toronto, Ontario, 캐나다, M5G 2M9
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Quebec
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Montreal, Quebec, 캐나다, H2L 4M1
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Montreal, Quebec, 캐나다, H2W 1S6
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Poznan, 폴란드, 61-866
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Warszawa, 폴란드, 02-781
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Warszawa, 폴란드, 04-125
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Boulogne-Billancourt, 프랑스, 92100
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Grenoble, 프랑스, 38043
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Montpellier, 프랑스, 34295
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Nantes, 프랑스, 44093
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Paris Cedex 10, 프랑스, 75475
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Pierre-Benite cedex, 프랑스, 69495
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Rennes, 프랑스, 35042
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Tours, 프랑스, 37044
- GSK Investigational Site
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Villejuif, 프랑스, 94805
- GSK Investigational Site
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Australian Capital Territory
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Garran, Australian Capital Territory, 호주, 2606
- GSK Investigational Site
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New South Wales
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Port Macquarie, New South Wales, 호주, 2444
- GSK Investigational Site
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Waratah, New South Wales, 호주, 2300
- GSK Investigational Site
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Queensland
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South Brisbane, Queensland, 호주, 4101
- GSK Investigational Site
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Townsville, Queensland, 호주, 4810
- GSK Investigational Site
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Woolloongabba, Queensland, 호주, 4102
- GSK Investigational Site
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South Australia
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Kurralta Park, South Australia, 호주, 5037
- GSK Investigational Site
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Woodville, South Australia, 호주, 5011
- GSK Investigational Site
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Victoria
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Heidelberg, Victoria, 호주, 3084
- GSK Investigational Site
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Melbourne, Victoria, 호주, 3004
- GSK Investigational Site
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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:
- ≥18 years of age
- Stage III unresectable (Stage IIIc) or metastatic (Stage IV) cutaneous melanoma which is also determined to be BRAF V600E/K mutation-positive by the central laboratory
- Received no prior treatment or up to one prior regimen of chemotherapy for advanced or metastatic melanoma. Prior treatment with immunotherapy (with the exception of prior ipilimumab, which is only allowed if given in the adjuvant setting), cytokine therapy, biological or vaccine regimen is permitted. Prior use of sorafenib is allowed
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- Women of childbearing potential and men with reproductive potential must agree to use effective contraception during the study. Additionally women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Adequate screening organ function
Exclusion Criteria:
- Any prior use of BRAF inhibitors or MEK inhibitors.
- Subjects who have received dacarbazine or paclitaxel prior to randomization will not be eligible to receive the same chemotherapy as study medication (i.e. a subject who received prior dacarbazine cannot receive dacarbazine on this trial and would thus receive paclitaxel if randomized to the control arm)
- History of another malignancy. Exception: Subjects who have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Subjects with second malignancies that are indolent or definitively treated may be enrolled. Consult GSK Medical Monitor if unsure whether second malignancies meet requirements specified above
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection which will be allowed)
- Brain metastases with the following exceptions that are ALL confirmed by the GSK Medical Monitor:
All known lesions must be previously treated with surgery or stereotactic radiosurgery, and Brain lesion(s), if still present, must be confirmed stable (i.e. no increase in lesion size) for ≥90 days prior to randomization (must be documented with two consecutive MRI or CT scans using contrast), and asymptomatic with no corticosteroids requirement for ≥ 30 days prior to randomization, and no enzyme-inducing anticonvulsants for ≥ 30 days prior to randomization
History or evidence of cardiovascular risk including any of the following:
- QTcB ≥ 480 msec.
- History or evidence of current clinically significant uncontrolled arrhythmias. Exception: Subjects with controlled atrial fibrillation for >30 days prior to randomization are eligible
- History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization.
- History or evidence of current ≥ Class II congestive heart failure as defined by New York Heart Association
- History of interstitial lung disease or pneumonitis
History or current evidence / risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR):
- History of RVO or CSR, or predisposing factors to RVO or CSR (e.g. uncontrolled glaucoma or ocular hypertension, uncontrolled hypertension, uncontrolled diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes).
- Visible retinal pathology as assessed by ophthalmic exam that is considered a risk factor for RVO or CSR such as:
- Evidence of new optic disc cupping.
- Intraocular pressure > 21 mm Hg as measured by tonography
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: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: GSK1120212
MEK inhibitor
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MEK 억제제
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활성 비교기: Chemotherapy
Investigator Choice of DTIC or paclitaxel
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Investigator Choice of DTIC or paclitaxel
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실험적: Crossover
MEK inhibitor after documented progression on Chemotherapy Arm
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MEK 억제제
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Progression-free Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases as Assessed by the Investigator and Independent Review
기간: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
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Progression-free survival (PFS) is defined as the time from randomization to the first documented occurrence of disease progression (PD) or death.
PFS for investigator-assessed and blinded, independent, central review committee (BRIC)-assessed responses was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment.
Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation.
Primary Efficacy Population included all participants with BRAF V600E mutation-positive melanoma without a history of brain metastases.
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Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression-free Survival in All Participants
기간: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
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PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death.
Investigator-assessed and BRIC-assessed PFS were summarized per RECIST, Version 1.1.
PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.
Intend-To-Treat (ITT) Population included all randomized participants regardless of whether or not treatment was administered.
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Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
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PFS in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases and Without Prior Chemotherapy as Assessed by the Investigator
기간: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
|
PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death.
Investigator-assessed PFS was summarized per RECIST, Version 1.1.
PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.
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Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
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PFS in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases and With Prior Chemotherapy as Assessed by the Investigator
기간: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
|
PFS is defined as the time from the date of randomization to the first documented occurrence of PD or death.
Investigator-assessed PFS was summarized per RECIST, Version 1.1.
PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.
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Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
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Overall Survival in All Participants
기간: Day 1 until death due to any cause (average of 20.3 months)
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Overall survival was defined as the time from the date of randomization to the date of death due to any cause.
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Day 1 until death due to any cause (average of 20.3 months)
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Overall Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases
기간: Day 1 until death due to any cause (average of 20.3 months)
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Overall survival was defined as the time from the date of randomization to the date of death due to any cause.
NA indicates data was not available.
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Day 1 until death due to any cause (average of 20.3 months)
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Number of BRAF V600E Mutation-positive Participants Without a History of Brain Metastases With Overall Response (OR) as Assessed by the Investigator and Independent Review
기간: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
|
OR is defined as the number of participants with evidence of complete response (CR; disappearance of all target lesions.
Any pathological lymph node must be less than 10 mm in the short axis) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator and an independent review per RECIST, Version 1.1.
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Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
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Number of Participants With OR as Assessed by the Investigator and Independent Review
기간: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
|
OR is defined as the number of participants with evidence of complete response (disappearance of all target lesions.
Any pathological lymph node must be less than 10 mm in the short axis) or partial response (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator and an independent review per RECIST, Version 1.1.
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Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
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Number of BRAF V600E Mutation-positive Participants Classified as Confirmed Responders (CR and PR) as Assessed by the Investigator
기간: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
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OR is defined as the number of participants with evidence of complete response (disappearance of all extranodal lesions.
Any pathological lymph node must be less than 10 mm in the short axis) or partial response (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator per RECIST, Version 1.1.
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Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
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Number of BRAF V600K Mutation-positive Participants Classified as Confirmed Responders (CR and PR) as Assessed by the Investigator
기간: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
|
OR is defined as the number of participants with evidence of complete response (CR; disappearance of all extranodal lesions.
Any pathological lymph node must be less than 10 mm in the short axis) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator per RECIST, Version 1.1.
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Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
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Number of Participants With OR Following Cross-over to Trametinib
기간: Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)
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OR is defined as the number of participants with evidence of CR (disappearance of all target lesions.
Any pathological lymph node must be less than 10 millimeters in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) evaluated by the Investigator in participants following cross-over to Trametinib.
The evaluation was carried out by the Investigator per RECIST, Version 1.1.
Cross-over Population included the subset of participants who were randomized to CT and who elected to cross-over to Trametinib following disease progression on CT.
Only participants who received at least one dose of Trametinib were included in this population.
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Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)
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Duration of Response (DoR) for All BRAF V600E Mutation-positive Participants Without a Prior History of Brain Metastases Classified as Confirmed Responders (CR or PR) as Assessed by the Investigator Review
기간: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
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DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions.
Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD (at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation) or death due to any cause.
DoR for the investigator-assessed (INVA) response data were summarized per RECIST, Version 1.1.
Only those participants with confirmed response (CR and PR) were analyzed.
Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
NA indicates data was not available.
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Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
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DoR for All BRAF V600E Mutation-positive Participants Without a Prior History of Brain Metastases Classified as Confirmed Responders (CR or PR) as Assessed by the Independent Review
기간: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
|
DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions.
Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD (at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation) or death due to any cause.
DoR for the independently-assessed (INDA) response data were summarized per RECIST, Version 1.1.
Only those participants with confirmed response (CR and PR) were analyzed.
Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
NA indicates data was not available.
|
Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
|
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DoR for All Confirmed Responders (CR or PR) as Assessed by the Investigator Review
기간: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
|
DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions.
Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause.
PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.
DoR for the INVA response data was summarized per RECIST, Version 1.1.
Only those participants with confirmed response (CR and PR) were analyzed.
Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
NA indicates data was not available.
|
Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
|
|
DoR for All Confirmed Responders (CR or PR) as Assessed by the Independent Review
기간: Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
|
DoR is defined as the time from the first documented evidence of CR (disappearance of all target lesions.
Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause.
PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.
DoR for the INDA response data was summarized per RECIST, Version 1.1.
Only those participants with confirmed response (CR and PR) were analyzed.
Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
NA indicates data was not available.
|
Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)
|
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DoR for All Responders (CR or PR) Following Cross-over to Trametinib as Assessed by the Investigator
기간: Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)
|
DoR is defined as the time from the first documented evidence of CR (disappearance of all extra nodal lesions.
Any pathological lymph node must be less than 10 mm in the short axis) or PR (at least a 30% decrease in the sum of the diameters of target lesions) until PD or death due to any cause.
PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.
DoR data were summarized per RECIST, Version 1.1Only those participants with confirmed response (CR and PR) were analyzed.
Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
NA indicates data was not available.
|
Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)
|
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PFS Following Cross-over to Trametinib as Assessed by the Investigator
기간: Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)
|
PFS is defined as the time from the first dose of cross-over therapy to the first documented occurrence of PD or death.
PFS was summarized per RECIST, Version 1.1.
PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions, or the worsening of non-target lesions significant enough to require study treatment discontinuation.
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Day 1 of cross-over therapy until the earliest date of disease progression or death due to any cause (average of 18.3 months)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
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
- Santiago-Walker A, Gagnon R, Mazumdar J, Casey M, Long GV, Schadendorf D, Flaherty K, Kefford R, Hauschild A, Hwu P, Haney P, O'Hagan A, Carver J, Goodman V, Legos J, Martin AM. Correlation of BRAF Mutation Status in Circulating-Free DNA and Tumor and Association with Clinical Outcome across Four BRAFi and MEKi Clinical Trials. Clin Cancer Res. 2016 Feb 1;22(3):567-74. doi: 10.1158/1078-0432.CCR-15-0321. Epub 2015 Oct 7.
- Flaherty KT, Robert C, Hersey P, Nathan P, Garbe C, Milhem M, Demidov LV, Hassel JC, Rutkowski P, Mohr P, Dummer R, Trefzer U, Larkin JM, Utikal J, Dreno B, Nyakas M, Middleton MR, Becker JC, Casey M, Sherman LJ, Wu FS, Ouellet D, Martin AM, Patel K, Schadendorf D; METRIC Study Group. Improved survival with MEK inhibition in BRAF-mutated melanoma. N Engl J Med. 2012 Jul 12;367(2):107-14. doi: 10.1056/NEJMoa1203421. Epub 2012 Jun 4.
- Robert C, Flaherty K, Nathan P, Hersey P, Garbe C, Milhem M, Demidov L, Mohr P, Hassel JC, Rutkowski P, Dummer R, Utikal J, Kiecker F, Larkin J, D'Amelio A Jr, Mookerjee B, Schadendorf D. Five-year outcomes from a phase 3 METRIC study in patients with BRAF V600 E/K-mutant advanced or metastatic melanoma. Eur J Cancer. 2019 Mar;109:61-69. doi: 10.1016/j.ejca.2018.12.015. Epub 2019 Jan 25.
- Latimer NR, Bell H, Abrams KR, Amonkar MM, Casey M. Adjusting for treatment switching in the METRIC study shows further improved overall survival with trametinib compared with chemotherapy. Cancer Med. 2016 May;5(5):806-15. doi: 10.1002/cam4.643. Epub 2016 Jan 27.
- Schadendorf D, Amonkar MM, Milhem M, Grotzinger K, Demidov LV, Rutkowski P, Garbe C, Dummer R, Hassel JC, Wolter P, Mohr P, Trefzer U, Lefeuvre-Plesse C, Rutten A, Steven N, Ullenhag G, Sherman L, Wu FS, Patel K, Casey M, Robert C. Functional and symptom impact of trametinib versus chemotherapy in BRAF V600E advanced or metastatic melanoma: quality-of-life analyses of the METRIC study. Ann Oncol. 2014 Mar;25(3):700-706. doi: 10.1093/annonc/mdt580. Epub 2014 Feb 6.
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)
2010년 11월 22일
기본 완료 (실제)
2011년 10월 26일
연구 완료 (실제)
2016년 12월 16일
연구 등록 날짜
최초 제출
2010년 11월 18일
QC 기준을 충족하는 최초 제출
2010년 11월 18일
처음 게시됨 (추정)
2010년 11월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 4월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 3월 9일
마지막으로 확인됨
2018년 1월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 114267
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. .