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

NCT01320085

CompletedPhase 2

Sponsor: Pfizer

Conditions: BRAF or NRAS Mutant Metastatic Melanoma

Interventions: MEK162

Countries: United States, Germany, Italy, Netherlands, Switzerland

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (25)
  • Fayetteville, Arkansas, United States
  • Tampa, Florida, United States
  • Portland, Oregon, United States
  • Portland, Oregon, United States
  • Portland, Oregon, United States
  • Allentown, Pennsylvania, United States
  • Allentown, Pennsylvania, United States
  • Bethlehem, Pennsylvania, United States
  • Bethlehem, Pennsylvania, United States
  • Quakertown, Pennsylvania, United States
  • Munich, Bavaria, Germany
  • München, Bavaria, Germany
  • Essen, North Rhine-Westphalia, Germany
  • Kiel, Schleswig-Holstein, Germany
  • Kiel, Schleswig-Holstein, Germany
  • Lübeck, Schleswig-Holstein, Germany
  • Gera, Thuringia, Germany
  • Munich, Germany
  • Genova, Italy
  • Naples, Italy
  • Nijmegen, Gelderland, Netherlands
  • Maastricht, Limburg, Netherlands
  • Amsterdam, North Holland, Netherlands
  • Amsterdam, North Holland, Netherlands
  • Zürich (de), Switzerland