- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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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, Austrálie, 2606
- GSK Investigational Site
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New South Wales
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Port Macquarie, New South Wales, Austrálie, 2444
- GSK Investigational Site
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Waratah, New South Wales, Austrálie, 2300
- GSK Investigational Site
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Queensland
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South Brisbane, Queensland, Austrálie, 4101
- GSK Investigational Site
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Townsville, Queensland, Austrálie, 4810
- GSK Investigational Site
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Woolloongabba, Queensland, Austrálie, 4102
- GSK Investigational Site
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South Australia
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Kurralta Park, South Australia, Austrálie, 5037
- GSK Investigational Site
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Woodville, South Australia, Austrálie, 5011
- GSK Investigational Site
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Victoria
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Heidelberg, Victoria, Austrálie, 3084
- GSK Investigational Site
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Melbourne, Victoria, Austrálie, 3004
- GSK Investigational Site
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Brussels, Belgie, 1200
- GSK Investigational Site
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Charleroi, Belgie, 6000
- GSK Investigational Site
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Gent, Belgie, 9000
- GSK Investigational Site
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Jette, Belgie, 1090
- GSK Investigational Site
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Kortrijk, Belgie, 8500
- GSK Investigational Site
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Leuven, Belgie, 3000
- GSK Investigational Site
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Wilrijk, Belgie, 2610
- GSK Investigational Site
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Yvoir, Belgie, 5530
- GSK Investigational Site
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Boulogne-Billancourt, Francie, 92100
- GSK Investigational Site
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Grenoble, Francie, 38043
- GSK Investigational Site
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Montpellier, Francie, 34295
- GSK Investigational Site
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Nantes, Francie, 44093
- GSK Investigational Site
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Paris Cedex 10, Francie, 75475
- GSK Investigational Site
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Pierre-Benite cedex, Francie, 69495
- GSK Investigational Site
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Rennes, Francie, 35042
- GSK Investigational Site
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Tours, Francie, 37044
- GSK Investigational Site
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Villejuif, Francie, 94805
- GSK Investigational Site
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Lombardia
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Milano, Lombardia, Itálie, 20132
- GSK Investigational Site
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Milano, Lombardia, Itálie, 20133
- GSK Investigational Site
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Milano, Lombardia, Itálie, 20141
- GSK Investigational Site
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Toscana
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Pisa, Toscana, Itálie, 56126
- GSK Investigational Site
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Alberta
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Calgary, Alberta, Kanada, T2N 4N2
- GSK Investigational Site
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z 4E6
- GSK Investigational Site
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 2Y9
- GSK Investigational Site
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Ontario
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Hamilton, Ontario, Kanada, L8V 5C2
- GSK Investigational Site
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London, Ontario, Kanada, N6A 4L6
- GSK Investigational Site
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Oshawa, Ontario, Kanada, L1G 2B9
- GSK Investigational Site
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Ottawa, Ontario, Kanada, K1H 8L6
- GSK Investigational Site
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Toronto, Ontario, Kanada, M5G 2M9
- GSK Investigational Site
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Quebec
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Montreal, Quebec, Kanada, H2L 4M1
- GSK Investigational Site
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Montreal, Quebec, Kanada, H2W 1S6
- GSK Investigational Site
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Oslo, Norsko, 0310
- GSK Investigational Site
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Christchurch, Nový Zéland, 8011
- GSK Investigational Site
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Dunedin, Nový Zéland, 9016
- GSK Investigational Site
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Newtown, Wellington, Nový Zéland, 6002
- GSK Investigational Site
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Berlin, Německo, 10117
- GSK Investigational Site
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Baden-Wuerttemberg
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Heidelberg, Baden-Wuerttemberg, Německo, 69120
- GSK Investigational Site
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Mannheim, Baden-Wuerttemberg, Německo, 68167
- GSK Investigational Site
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Tuebingen, Baden-Wuerttemberg, Německo, 72076
- GSK Investigational Site
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Bayern
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Muenchen, Bayern, Německo, 80804
- GSK Investigational Site
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Wuerzburg, Bayern, Německo, 97080
- GSK Investigational Site
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Niedersachsen
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Buxtehude, Niedersachsen, Německo, 21614
- GSK Investigational Site
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Nordrhein-Westfalen
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Essen, Nordrhein-Westfalen, Německo, 45122
- GSK Investigational Site
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Sachsen
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Dresden, Sachsen, Německo, 01307
- GSK Investigational Site
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Schleswig-Holstein
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Luebeck, Schleswig-Holstein, Německo, 23538
- GSK Investigational Site
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Poznan, Polsko, 61-866
- GSK Investigational Site
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Warszawa, Polsko, 02-781
- GSK Investigational Site
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Warszawa, Polsko, 04-125
- GSK Investigational Site
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Graz, Rakousko, 8036
- GSK Investigational Site
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Wien, Rakousko, 1090
- GSK Investigational Site
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Chelyabinsk, Ruská Federace, 454087
- GSK Investigational Site
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Magnitogorsk, Ruská Federace, 455001
- GSK Investigational Site
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Moscow, Ruská Federace, 115478
- GSK Investigational Site
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St. Petersburg, Ruská Federace, 197758
- GSK Investigational Site
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Aberdeen, Spojené království, AB25 2ZN
- GSK Investigational Site
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Birmingham, Spojené království, B15 2TH
- GSK Investigational Site
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Chelmsford, Spojené království, CM1 7ET
- GSK Investigational Site
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Leeds, Spojené království, LS9 7TF
- GSK Investigational Site
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London, Spojené království, SW3 6JJ
- GSK Investigational Site
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London, Spojené království, W1G 6AD
- GSK Investigational Site
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Manchester, Spojené království, M20 4BX
- GSK Investigational Site
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Oxford, Spojené království, OX3 7LJ
- GSK Investigational Site
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Southampton, Spojené království, SO16 6YD
- GSK Investigational Site
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Cambridgeshire
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Cambridge, Cambridgeshire, Spojené království, CB2 2QQ
- GSK Investigational Site
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Middlesex
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Northwood, Middlesex, Spojené království, HA6 2RN
- GSK Investigational Site
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Surrey
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Sutton, Surrey, Spojené království, SM2 5PT
- GSK Investigational Site
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Arizona
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Tucson, Arizona, Spojené státy, 85724-5024
- GSK Investigational Site
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Florida
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Fort Myers, Florida, Spojené státy, 33916
- GSK Investigational Site
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Georgia
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Athens, Georgia, Spojené státy, 30607
- GSK Investigational Site
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Marietta, Georgia, Spojené státy, 30060
- GSK Investigational Site
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Iowa
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Iowa City, Iowa, Spojené státy, 52242
- GSK Investigational Site
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Louisiana
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Metairie, Louisiana, Spojené státy, 70006
- GSK Investigational Site
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02114
- GSK Investigational Site
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New Jersey
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Morristown, New Jersey, Spojené státy, 07962-1956
- GSK Investigational Site
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Ohio
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Columbus, Ohio, Spojené státy, 43210
- GSK Investigational Site
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South Carolina
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Columbia, South Carolina, Spojené státy, 29210
- GSK Investigational Site
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Tennessee
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Chattanooga, Tennessee, Spojené státy, 37404
- GSK Investigational Site
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Memphis, Tennessee, Spojené státy, 38120
- GSK Investigational Site
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Nashville, Tennessee, Spojené státy, 37203
- GSK Investigational Site
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Dnepropetrovsk, Ukrajina, 49102
- GSK Investigational Site
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Kharkiv, Ukrajina, 61070
- GSK Investigational Site
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Kyiv, Ukrajina, 03022
- GSK Investigational Site
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Kyiv, Ukrajina, 03115
- GSK Investigational Site
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Lviv, Ukrajina, 79031
- GSK Investigational Site
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Sumy, Ukrajina, 40005
- GSK Investigational Site
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Sympheropol, Ukrajina, 95023
- GSK Investigational Site
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Ternopil, Ukrajina, 46023
- GSK Investigational Site
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Uzhgorod, Ukrajina, 88017
- GSK Investigational Site
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Hradec Kralove, Česko, 500 05
- GSK Investigational Site
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Ostrava, Česko, 708 52
- GSK Investigational Site
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Praha 2, Česko, 128 08
- GSK Investigational Site
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Zlin, Česko, 76275
- GSK Investigational Site
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Athens, Řecko, 11527
- GSK Investigational Site
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Athens, Řecko, 185 47
- GSK Investigational Site
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Thessaloniki, Řecko, 564 29
- GSK Investigational Site
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Goteborg, Švédsko, SE-413 45
- GSK Investigational Site
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Linkoping, Švédsko, SE-581 85
- GSK Investigational Site
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Lund, Švédsko, SE-221 85
- GSK Investigational Site
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Stockholm, Švédsko, SE-171 76
- GSK Investigational Site
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Uppsala, Švédsko, SE-751 85
- GSK Investigational Site
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Zurich, Švýcarsko, 8091
- GSK Investigational Site
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: GSK1120212
MEK inhibitor
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Inhibitor MEK
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Aktivní komparátor: Chemotherapy
Investigator Choice of DTIC or paclitaxel
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Investigator Choice of DTIC or paclitaxel
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Experimentální: Crossover
MEK inhibitor after documented progression on Chemotherapy Arm
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Inhibitor MEK
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Progression-free Survival in All Participants
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Novotvary podle histologického typu
- Novotvary
- Neuroektodermální nádory
- Novotvary, zárodečné buňky a embryonální
- Novotvary, nervová tkáň
- Neuroendokrinní nádory
- Nevi a melanomy
- Melanom
- Molekulární mechanismy farmakologického působení
- Inhibitory enzymů
- Antineoplastická činidla
- Inhibitory proteinkinázy
- Trametinib
Další identifikační čísla studie
- 114267
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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Klinické studie na Melanom
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H. Lee Moffitt Cancer Center and Research InstituteTurnstone Biologics, Corp.NáborMetastatický melanom | Konjunktivální melanom | Oční melanom | Neresekovatelný melanom | Uveální melanom | Kožní melanom | Slizniční melanom | Melanom duhovky | Akrální melanom | Nekutánní melanomSpojené státy
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University of Southern CaliforniaNational Cancer Institute (NCI)DokončenoRecidivující melanom | Melanom fáze IV | Slizniční melanom | Melanom řasnatého tělíska a cévnatky, střední/velký | Melanom řasnatého tělíska a cévnatky, malá velikost | Melanom duhovky | Metastatický nitrooční melanom | Recidivující nitrooční melanom | Nitrooční melanom stadia IV | Melanom stadia IIIA | Melanom... a další podmínkySpojené státy
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National Cancer Institute (NCI)DokončenoRecidivující melanom | Melanom stadia IIIA | Melanom stadia IIIB | Melanom stadia IIIC | Melanom stadia IIB | Melanom stadia IIC | Melanom stadia IA | Melanom stadia IB | Melanom stadia IIASpojené státy
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); University of VirginiaDokončenoStádium IIIB kožní melanom | Stádium IIIC kožní melanom | Stupeň III kožní melanom | Melanom kůže stadia IIA | Melanom kůže stadia IIB | Kožní melanom stadia IIC | Stádium IIIA kožní melanom | Stádium IA kožní melanom | Stádium IB kožní melanom | Stádium 0 kožní melanom | Stádium I kožní melanom | Melanom kůže IISpojené státy
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National Cancer Institute (NCI)DokončenoMelanom fáze IV | Melanom řasnatého tělíska a cévnatky, střední/velký | Melanom duhovky | Melanom stadia IIIA | Melanom stadia IIIB | Melanom stadia IIIC | Extraokulární extenzní melanom | Melanom stadia IIB | Melanom stadia IICSpojené státy
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MelanomaPRO, RussiaNáborKlinické výsledky a biomarkery u pacientů s melanomem stadia 0-IV v reálné klinické praxi (ISABELLA)Melanom | Melanom (kůže) | Melanom stadium IV | Melanom stadium III | Melanom, stadium II | Melanom, Uveal | Melanom na místě | Melanom, očníRuská Federace
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Mayo ClinicNational Cancer Institute (NCI)DokončenoRecidivující melanom | Melanom fáze IV | Melanom stadia IIIA | Melanom stadia IIIB | Melanom stadia IIIC | Melanom stadia IIB | Melanom stadia IIC | Melanom stadia IIASpojené státy
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BiocadNáborMelanom | Melanom (kůže) | Melanom stadium IV | Melanom stadium III | Metastatický melanom | Neresekovatelný melanom | Pokročilý melanomIndie, Ruská Federace, Bělorusko
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Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Comprehensive Cancer NetworkUkončenoRecidivující melanom | Melanom fáze IV | Metastatický nitrooční melanom | Recidivující nitrooční melanom | Nitrooční melanom stadia IV | Melanom stadia IIIA | Melanom stadia IIIB | Melanom stadia IIIC | Extraokulární extenzní melanom | Nitrooční melanom stadia IIIA | Nitrooční melanom stadia IIIB | Nitrooční melanom...Spojené státy
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)DokončenoStupeň IV kožní melanom | Recidivující melanom | Stádium IIIB kožní melanom | Stádium IIIC kožní melanom | Melanom kůže stadia IIA | Melanom kůže stadia IIB | Kožní melanom stadia IIC | Stádium IIIA kožní melanom | Stádium IA kožní melanom | Stádium IB kožní melanomSpojené státy
Klinické studie na GSK1120212
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Novartis PharmaceuticalsUkončenoRakovinaFrancie, Spojené státy, Holandsko, Kanada, Tchaj-wan, Korejská republika
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National Cancer Institute (NCI)Aktivní, ne náborPokročilý maligní solidní novotvar | Metastatický maligní solidní novotvar | Metastatický maligní novotvar v játrech | Neresekovatelný pevný novotvarSpojené státy, Kanada
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Jonsson Comprehensive Cancer CenterNovartis; Stand Up To Cancer; Prostate Cancer FoundationAktivní, ne náborTrametinib v léčbě pacientů s progresivním metastatickým karcinomem prostaty rezistentním na hormonyMetastatický karcinom prostaty | Recidivující karcinom prostaty | Rakovina prostaty ve stádiu IV | Hormonálně rezistentní rakovina prostatySpojené státy
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National Cancer Institute (NCI)Children's Oncology GroupAktivní, ne náborJuvenilní myelomonocytární leukémie | Neurofibromatóza typu 1Spojené státy
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National Cancer Institute (NCI)DokončenoLokálně pokročilý epitelioidní hemangioendoteliom | Metastatický epitelioidní hemangioendoteliom | Neresekabilní epitelioidní hemangioendoteliomSpojené státy
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National Cancer Institute (NCI)DokončenoRefrakterní plazmatický buněčný myelom | Recidivující plazmatický myelomKanada
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National Cancer Institute (NCI)DokončenoStádium IV uveálního melanomu AJCC v7 | Recidivující uveální melanomSpojené státy, Francie, Spojené království
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National Cancer Institute (NCI)UkončenoRekurentní akutní myeloidní leukémie dospělých | Neléčená akutní myeloidní leukémie dospělýchSpojené státy
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National Cancer Institute (NCI)GlaxoSmithKlineDokončenoRakovina prsu ve stádiu IV | Recidivující karcinom prsu | Invazivní karcinom prsu | Estrogenový receptor negativní | HER2/Neu negativní | Negativní progesteronový receptor | Triple-negativní karcinom prsuSpojené státy
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National Cancer Institute (NCI)NRG OncologyDokončenoEndometriální průhledný adenokarcinom | Endometriální smíšený buněčný adenokarcinom | Endometriální serózní adenokarcinom | Endometriální nediferencovaný karcinom | Endometriální adenokarcinom | Recidivující rakovina děložního tělaSpojené státy