- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01245062
GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma
A Phase III Randomized, Open-label Study Comparing GSK1120212 to Chemotherapy in Subjects With Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Ciudad Autonoma de Buenos Aires, Argentina, C1121ABE
- GSK Investigational Site
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Australian Capital Territory
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Garran, Australian Capital Territory, Australien, 2606
- GSK Investigational Site
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New South Wales
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Port Macquarie, New South Wales, Australien, 2444
- GSK Investigational Site
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Waratah, New South Wales, Australien, 2300
- GSK Investigational Site
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Queensland
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South Brisbane, Queensland, Australien, 4101
- GSK Investigational Site
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Townsville, Queensland, Australien, 4810
- GSK Investigational Site
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Woolloongabba, Queensland, Australien, 4102
- GSK Investigational Site
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South Australia
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Kurralta Park, South Australia, Australien, 5037
- GSK Investigational Site
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Woodville, South Australia, Australien, 5011
- GSK Investigational Site
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Victoria
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Heidelberg, Victoria, Australien, 3084
- GSK Investigational Site
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Melbourne, Victoria, Australien, 3004
- GSK Investigational Site
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Brussels, Belgien, 1200
- GSK Investigational Site
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Charleroi, Belgien, 6000
- GSK Investigational Site
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Gent, Belgien, 9000
- GSK Investigational Site
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Jette, Belgien, 1090
- GSK Investigational Site
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Kortrijk, Belgien, 8500
- GSK Investigational Site
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Leuven, Belgien, 3000
- GSK Investigational Site
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Wilrijk, Belgien, 2610
- GSK Investigational Site
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Yvoir, Belgien, 5530
- GSK Investigational Site
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- GSK Investigational Site
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- GSK Investigational Site
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
- GSK Investigational Site
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- GSK Investigational Site
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London, Ontario, Canada, N6A 4L6
- GSK Investigational Site
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Oshawa, Ontario, Canada, L1G 2B9
- GSK Investigational Site
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Ottawa, Ontario, Canada, K1H 8L6
- GSK Investigational Site
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Toronto, Ontario, Canada, M5G 2M9
- GSK Investigational Site
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Quebec
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Montreal, Quebec, Canada, H2L 4M1
- GSK Investigational Site
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Montreal, Quebec, Canada, H2W 1S6
- GSK Investigational Site
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Chelyabinsk, Den Russiske Føderation, 454087
- GSK Investigational Site
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Magnitogorsk, Den Russiske Føderation, 455001
- GSK Investigational Site
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Moscow, Den Russiske Føderation, 115478
- GSK Investigational Site
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St. Petersburg, Den Russiske Føderation, 197758
- GSK Investigational Site
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Aberdeen, Det Forenede Kongerige, AB25 2ZN
- GSK Investigational Site
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Birmingham, Det Forenede Kongerige, B15 2TH
- GSK Investigational Site
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Chelmsford, Det Forenede Kongerige, CM1 7ET
- GSK Investigational Site
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Leeds, Det Forenede Kongerige, LS9 7TF
- GSK Investigational Site
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London, Det Forenede Kongerige, SW3 6JJ
- GSK Investigational Site
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London, Det Forenede Kongerige, W1G 6AD
- GSK Investigational Site
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Manchester, Det Forenede Kongerige, M20 4BX
- GSK Investigational Site
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Oxford, Det Forenede Kongerige, OX3 7LJ
- GSK Investigational Site
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Southampton, Det Forenede Kongerige, SO16 6YD
- GSK Investigational Site
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Cambridgeshire
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Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 2QQ
- GSK Investigational Site
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Middlesex
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Northwood, Middlesex, Det Forenede Kongerige, HA6 2RN
- GSK Investigational Site
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Surrey
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Sutton, Surrey, Det Forenede Kongerige, SM2 5PT
- GSK Investigational Site
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Arizona
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Tucson, Arizona, Forenede Stater, 85724-5024
- GSK Investigational Site
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Florida
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Fort Myers, Florida, Forenede Stater, 33916
- GSK Investigational Site
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Georgia
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Athens, Georgia, Forenede Stater, 30607
- GSK Investigational Site
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Marietta, Georgia, Forenede Stater, 30060
- GSK Investigational Site
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- GSK Investigational Site
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Louisiana
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Metairie, Louisiana, Forenede Stater, 70006
- GSK Investigational Site
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- GSK Investigational Site
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New Jersey
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Morristown, New Jersey, Forenede Stater, 07962-1956
- GSK Investigational Site
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Ohio
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Columbus, Ohio, Forenede Stater, 43210
- GSK Investigational Site
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South Carolina
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Columbia, South Carolina, Forenede Stater, 29210
- GSK Investigational Site
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37404
- GSK Investigational Site
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Memphis, Tennessee, Forenede Stater, 38120
- GSK Investigational Site
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Nashville, Tennessee, Forenede Stater, 37203
- GSK Investigational Site
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Boulogne-Billancourt, Frankrig, 92100
- GSK Investigational Site
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Grenoble, Frankrig, 38043
- GSK Investigational Site
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Montpellier, Frankrig, 34295
- GSK Investigational Site
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Nantes, Frankrig, 44093
- GSK Investigational Site
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Paris Cedex 10, Frankrig, 75475
- GSK Investigational Site
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Pierre-Benite cedex, Frankrig, 69495
- GSK Investigational Site
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Rennes, Frankrig, 35042
- GSK Investigational Site
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Tours, Frankrig, 37044
- GSK Investigational Site
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Villejuif, Frankrig, 94805
- GSK Investigational Site
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Athens, Grækenland, 11527
- GSK Investigational Site
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Athens, Grækenland, 185 47
- GSK Investigational Site
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Thessaloniki, Grækenland, 564 29
- GSK Investigational Site
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Lombardia
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Milano, Lombardia, Italien, 20132
- GSK Investigational Site
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Milano, Lombardia, Italien, 20133
- GSK Investigational Site
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Milano, Lombardia, Italien, 20141
- GSK Investigational Site
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Toscana
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Pisa, Toscana, Italien, 56126
- GSK Investigational Site
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Christchurch, New Zealand, 8011
- GSK Investigational Site
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Dunedin, New Zealand, 9016
- GSK Investigational Site
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Newtown, Wellington, New Zealand, 6002
- GSK Investigational Site
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Oslo, Norge, 0310
- GSK Investigational Site
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Poznan, Polen, 61-866
- GSK Investigational Site
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Warszawa, Polen, 02-781
- GSK Investigational Site
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Warszawa, Polen, 04-125
- GSK Investigational Site
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Zurich, Schweiz, 8091
- GSK Investigational Site
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Goteborg, Sverige, SE-413 45
- GSK Investigational Site
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Linkoping, Sverige, SE-581 85
- GSK Investigational Site
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Lund, Sverige, SE-221 85
- GSK Investigational Site
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Stockholm, Sverige, SE-171 76
- GSK Investigational Site
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Uppsala, Sverige, SE-751 85
- GSK Investigational Site
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Hradec Kralove, Tjekkiet, 500 05
- GSK Investigational Site
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Ostrava, Tjekkiet, 708 52
- GSK Investigational Site
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Praha 2, Tjekkiet, 128 08
- GSK Investigational Site
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Zlin, Tjekkiet, 76275
- GSK Investigational Site
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Berlin, Tyskland, 10117
- GSK Investigational Site
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Baden-Wuerttemberg
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Heidelberg, Baden-Wuerttemberg, Tyskland, 69120
- GSK Investigational Site
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Mannheim, Baden-Wuerttemberg, Tyskland, 68167
- GSK Investigational Site
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Tuebingen, Baden-Wuerttemberg, Tyskland, 72076
- GSK Investigational Site
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Bayern
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Muenchen, Bayern, Tyskland, 80804
- GSK Investigational Site
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Wuerzburg, Bayern, Tyskland, 97080
- GSK Investigational Site
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Niedersachsen
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Buxtehude, Niedersachsen, Tyskland, 21614
- GSK Investigational Site
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Nordrhein-Westfalen
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Essen, Nordrhein-Westfalen, Tyskland, 45122
- GSK Investigational Site
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Sachsen
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Dresden, Sachsen, Tyskland, 01307
- GSK Investigational Site
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Schleswig-Holstein
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Luebeck, Schleswig-Holstein, Tyskland, 23538
- GSK Investigational Site
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Dnepropetrovsk, Ukraine, 49102
- GSK Investigational Site
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Kharkiv, Ukraine, 61070
- GSK Investigational Site
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Kyiv, Ukraine, 03022
- GSK Investigational Site
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Kyiv, Ukraine, 03115
- GSK Investigational Site
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Lviv, Ukraine, 79031
- GSK Investigational Site
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Sumy, Ukraine, 40005
- GSK Investigational Site
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Sympheropol, Ukraine, 95023
- GSK Investigational Site
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Ternopil, Ukraine, 46023
- GSK Investigational Site
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Uzhgorod, Ukraine, 88017
- GSK Investigational Site
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Graz, Østrig, 8036
- GSK Investigational Site
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Wien, Østrig, 1090
- GSK Investigational Site
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: GSK1120212
MEK inhibitor
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MEK-hæmmer
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Aktiv komparator: Chemotherapy
Investigator Choice of DTIC or paclitaxel
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Investigator Choice of DTIC or paclitaxel
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Eksperimentel: Crossover
MEK inhibitor after documented progression on Chemotherapy Arm
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MEK-hæmmer
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Progression-free Survival in All Participants
Tidsramme: 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
Tidsramme: 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 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
Tidsramme: 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 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 (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
Tidsramme: 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 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
Tidsramme: 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
Tidsramme: 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 (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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 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.
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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 Confirmed Responders (CR or PR) as Assessed by the Investigator Review
Tidsramme: 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 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.
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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 Confirmed Responders (CR or PR) as Assessed by the Independent Review
Tidsramme: 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.
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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 Responders (CR or PR) Following Cross-over to Trametinib as Assessed by the Investigator
Tidsramme: 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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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.
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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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PFS Following Cross-over to Trametinib as Assessed by the Investigator
Tidsramme: 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 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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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 114267
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Melanom
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National Cancer Institute (NCI)ExelisisAfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanom | Stage III Uveal Melanoma AJCC v7 | Stage IIIA Uveal Melanoma AJCC v7 | Stadie IIIB Uveal Melanoma AJCC v7 | Stage IIIC Uveal Melanoma AJCC v7Forenede Stater, Canada
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National Cancer Institute (NCI)AfsluttetFase IV kutan melanom AJCC v6 og v7 | Tilbagevendende melanom | Fase IIIC kutan melanom AJCC v7 | Slimhinde melanom | Iris melanom | Fase IIIA kutan melanom AJCC v7 | Fase IIIB kutan melanom AJCC v7 | Stage IV Uveal Melanoma AJCC v7 | Medium/Large Size Posterior Uveal Melanom | Tilbagevendende uveal melanom | Stage IIIA Uveal Melanoma AJCC v7 og andre forholdForenede Stater
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)AfsluttetFase IV kutan melanom AJCC v6 og v7 | Okulært melanom | Fase IIIC kutan melanom AJCC v7 | Kutant melanom | Slimhinde melanom | Fase IIIB kutan melanom AJCC v7 | Stage IV Uveal Melanoma AJCC v7 | Stadie IIIB Uveal Melanoma AJCC v7 | Stage IIIC Uveal Melanoma AJCC v7 | Stadie III Akral Lentiginøst Melanom AJCC... og andre forholdForenede Stater
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Sidney Kimmel Cancer Center at Thomas Jefferson...PfizerAktiv, ikke rekrutterendeCiliær krop og choroid melanom, medium/stor størrelse | Ciliær krop og choroidea melanom, lille størrelse | Iris melanom | Stadium IIIA Intraokulært melanom | Stadium IIIB Intraokulært melanom | Stadie IIIC Intraokulært melanom | Stadie I Intraokulært melanom | Stadie IIA Intraokulært melanom | Stadie IIB... og andre forholdForenede Stater
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National Cancer Institute (NCI)Memorial Sloan Kettering Cancer Center; Institut Curie Paris; Moffitt Cancer...Aktiv, ikke rekrutterendeMetastatisk uveal melanom | Stage IV Uveal Melanoma AJCC v7Forenede Stater
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Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)AfsluttetMetastatisk melanom | Fase IV kutan melanom AJCC v6 og v7 | Uoperabelt melanom | Slimhinde melanom | Stage IV Uveal Melanoma AJCC v7Forenede Stater
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National Cancer Institute (NCI)AfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanomForenede Stater
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National Cancer Institute (NCI)AfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanomForenede Stater, Frankrig, Det Forenede Kongerige
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeMetastatisk uveal melanom | Stage IV Uveal Melanoma AJCC v7Forenede Stater
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Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbAktiv, ikke rekrutterendeMetastatisk uveal melanom | Metastatisk malign neoplasma i leveren | Stage IV Uveal Melanoma AJCC v7Forenede Stater
Kliniske forsøg med GSK1120212
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Novartis PharmaceuticalsAfsluttetKræftFrankrig, Forenede Stater, Holland, Canada, Taiwan, Korea, Republikken
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Jonsson Comprehensive Cancer CenterNovartis; Stand Up To Cancer; Prostate Cancer FoundationAktiv, ikke rekrutterendeMetastatisk prostatakarcinom | Tilbagevendende prostatakarcinom | Stadie IV prostatakræft | Hormon-resistent prostatakræftForenede Stater
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National Cancer Institute (NCI)Aktiv, ikke rekrutterendeAvanceret malignt fast neoplasma | Metastatisk malignt fast neoplasma | Metastatisk malign neoplasma i leveren | Uoprettelig fast neoplasmaForenede Stater, Canada
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National Cancer Institute (NCI)Children's Oncology GroupAktiv, ikke rekrutterendeJuvenil myelomonocytisk leukæmi | Neurofibromatose type 1Forenede Stater
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National Cancer Institute (NCI)AfsluttetLokalt avanceret epithelioid hæmangioendotheliom | Metastatisk epithelioid hæmangioendotheliom | Uoperabelt epithelioid hæmangioendotheliomForenede Stater
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National Cancer Institute (NCI)AfsluttetRefraktært plasmacellemyelom | Tilbagevendende plasmacellemyelomCanada
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National Cancer Institute (NCI)AfsluttetStage IV Uveal Melanoma AJCC v7 | Tilbagevendende uveal melanomForenede Stater, Frankrig, Det Forenede Kongerige
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National Cancer Institute (NCI)GlaxoSmithKlineAfsluttetStadie IV brystkræft | Tilbagevendende brystkarcinom | Invasivt brystkarcinom | Østrogenreceptor negativ | HER2/Neu negativ | Progesteronreceptor negativ | Triple-negativt brystkarcinomForenede Stater
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National Cancer Institute (NCI)AfsluttetTilbagevendende akut myeloid leukæmi hos voksne | Ubehandlet akut myeloid leukæmi hos voksneForenede Stater
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National Cancer Institute (NCI)NRG OncologyAfsluttetEndometrie clear cell adenocarcinoma | Endometrie blandet cellet adenokarcinom | Endometrial serøst adenokarcinom | Endometrielt udifferentieret karcinom | Endometrial Adenocarcinom | Tilbagevendende livmoderkræftForenede Stater