A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma
NCT ID: NCT01320085
Last Updated: 2024-01-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
183 participants
INTERVENTIONAL
2011-03-24
2023-02-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BRAFV600 mutant, 45mg bid MEK162
BRAFV600 mutant, 45mg bid MEK162
MEK162
NRAS mutant, 45mg bid MEK162
NRAS mutant, 45mg bid MEK162
MEK162
BRAFV600 mutant, 60mg bid MEK162
BRAFV600 mutant, 60mg bid MEK162
MEK162
Interventions
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MEK162
Eligibility Criteria
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Inclusion Criteria
* BRAF or NRAS mutation in tumor tissue
* All patients enrolled should provide sufficient fresh or archival tumor sample at baseline to enable confirmation of BRAF or NRAS mutations and the additional analyses described in the protocol
* Evidence of measurable tumor disease as per RECIST
* WHO performance status of 0-2
* Adequate organ function and laboratory parameters
Exclusion Criteria
* Patients with unstable CNS metastasis
* Prior treatment with a MEK- inhibitor
* Impaired cardiovascular function
* HIV, active Hepatitis B, and/or active Hepatitis C infection
* Pregnant or nursing (lactating) women
* Women of child-bearing potential UNLESS they comply with protocol contraceptive requirements
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Highlands Oncology Group
Fayetteville, Arkansas, United States
H. Lee Moffitt Cancer Center & Research Institute, Inc.
Tampa, Florida, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States
OHSU Center for Health and Healing
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Cancer Care Associates Medical Oncology
Allentown, Pennsylvania, United States
St. Luke's Cancer Center - Allentown Campus
Allentown, Pennsylvania, United States
Cancer Care Associates Medical Oncology
Bethlehem, Pennsylvania, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
St. Luke's Hospital - Quakertown Campus
Quakertown, Pennsylvania, United States
LMU Klinikum der Universität
Munich, Bavaria, Germany
LMU Klinikum der Universität München
München, Bavaria, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Universitatsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany
Universitatsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany
Universitatsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
SRH Wald-Klinikum Gera GmbH
Gera, Thuringia, Germany
LMU Klinikum der Universität München
Munich, , Germany
Istituto nazionale Per la Ricerca sul Cancro
Genova, , Italy
Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale
Napoli, , Italy
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, North Holland, Netherlands
Slotervaartziekenhuis
Amsterdam, North Holland, Netherlands
Universitätsspital Zürich
Zürich (de), , Switzerland
Countries
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References
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Ascierto PA, Schadendorf D, Berking C, Agarwala SS, van Herpen CM, Queirolo P, Blank CU, Hauschild A, Beck JT, St-Pierre A, Niazi F, Wandel S, Peters M, Zubel A, Dummer R. MEK162 for patients with advanced melanoma harbouring NRAS or Val600 BRAF mutations: a non-randomised, open-label phase 2 study. Lancet Oncol. 2013 Mar;14(3):249-56. doi: 10.1016/S1470-2045(13)70024-X. Epub 2013 Feb 13.
Other Identifiers
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C4211001
Identifier Type: OTHER
Identifier Source: secondary_id
2010-023412-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CMEK162X2201
Identifier Type: -
Identifier Source: org_study_id
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