Overview

This trial is active, not recruiting.

Condition braf or nras mutant metastatic melanoma
Treatment mek162
Phase phase 2
Target MEK
Sponsor Array BioPharma
Start date March 2011
End date December 2016
Trial size 183 participants
Trial identifier NCT01320085, 2010-023412-13, CMEK162X2201

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
BRAFV600 mutant, 45mg bid
mek162
(Experimental)
NRAS mutant, 45mg bid
mek162
(Experimental)
BRAFV600 mutant, 60mg bid
mek162

Primary Outcomes

Measure
Overall response rate (ORR) - Efficacy
time frame: every 8 weeks up to end of study

Secondary Outcomes

Measure
Progression Free SUurvival (PFS)
time frame: every 8 weeks up to end of study
Overall Survival, Duration of response (DoR) and Time to Response
time frame: every 8-12 weeks up to end of study
Frequency and severity of adverse events and changes in laboratory values
time frame: every 30 days after last dose
Change in pharmacodynamics pre- and post-dose
time frame: After 15 days of dosing

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Phase II, Open-label Study to Assess the Safety and Efficacy of Oral MEK162 in Adults With Locally Advanced and Unresectable or Metastatic Malignant Cutaneous Melanoma, Harboring BRAFV600 or NRAS Mutations
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Array BioPharma.