Melanoma Clinical Trial

A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma

Summary

The study will assess the safety and efficacy of single-agent MEK162 in adult patients with locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring BRAFV600E or NRAS mutations.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Locally advanced or metastatic cutaneous melanoma AJCC Stage IIIB to IV, not potentially curable with surgery
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:

History or evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or any eye condition that would be considered a risk factor for CSR or RVO
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

Other protocol-defined inclusion/exclusion criteria may apply.

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

183

Study ID:

NCT01320085

Recruitment Status:

Active, not recruiting

Sponsor:

Pfizer

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There are 16 Locations for this study

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Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
H. Lee Moffitt Cancer Center & Research Institute, Inc.
Tampa Florida, 33612, United States
OHSU Knight Cancer Institute
Portland Oregon, 97201, United States
OHSU Center for Health and Healing
Portland Oregon, 97239, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Cancer Care Associates Medical Oncology
Allentown Pennsylvania, 18104, United States
St. Luke's Cancer Center - Allentown Campus
Allentown Pennsylvania, 18104, United States
Cancer Care Associates Medical Oncology
Bethlehem Pennsylvania, 18015, United States
St. Luke's University Health Network
Bethlehem Pennsylvania, 18015, United States
St. Luke's Hospital - Quakertown Campus
Quakertown Pennsylvania, 18951, United States
LMU Klinikum der Universität
Muenchen Bayern, 80337, Germany
LMU Klinikum der Universität München
München Bayern, 80337, Germany
Universitätsklinikum Essen
Essen Nordrhein-westfalen, 45122, Germany
Universitatsklinikum Schleswig-Holstein
Luebeck Schleswig-holstein, 23562, Germany
Istituto nazionale Per la Ricerca sul Cancro
Genova , 16132, Italy
Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale
Napoli , 80131, Italy
Radboud University Nijmegen Medical Centre
Nijmegen Gelderland, 6525 , Netherlands
Maastricht University Medical Center
Maastricht Limburg, 6229 , Netherlands
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam Noord-holland, 1066 , Netherlands
Slotervaartziekenhuis
Amsterdam Noord-holland, 1066 , Netherlands
Universitätsspital Zürich
Zürich (de) , 08091, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

183

Study ID:

NCT01320085

Recruitment Status:

Active, not recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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