This trial is active, not recruiting.

Condition advanced solid tumor
Treatment mek162
Phase phase 1
Target MEK
Sponsor Array BioPharma
Start date November 2011
End date April 2014
Trial size 21 participants
Trial identifier NCT01469130, CMEK162X1101


In this study, MEK162 will be administered to Japanese patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will investigate the safety and tolerability and determine the MTD of MEK162 in Japanese patients.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
MEK162 will be administered orally once on Day 1 of Cycle 1 and continuously on a BID schedule, starting on Day 2 of Cycle 1 and on Day 1 of subsequent cycles. Each cycle will be 28 days in duration. Dose will be escalated and starting dose is 30 mg. Any doses that are missed should be skipped and should not be replaced or made up during the evening dosing or on a subsequent day, whichever applies. The prescribed BID doses should be taken 12 ± 2 hrs apart.
MEK162 in an oral formulation. It is a film-coated capsule-shape tablets (i.e. caplets).

Primary Outcomes

Incidence of Dose limiting toxicities
time frame: 4 weeks

Secondary Outcomes

Incidence and severity of adverse events and serious adverse events, changes in laboratory values
time frame: 4 months
Plasma concentration of MEK162 and AR00426032active metabolite of MEK162 and derived PK parameters of MEK162 and the active metabolite.
time frame: 2 months
Tumor responses according to RECIST 1.1
time frame: 4 months
Levels of p-ERK in tumor and skin
time frame: 4 months

Eligibility Criteria

All participants at least 18 years old.

Inclusion Criteria: - Patients with histologically-confirmed, advanced unresectable solid tumors who have progressed within three months before screening/baseline visit. - Availability of a representative formalin fixed paraffin embedded tumor tissue sample. - At least one measurable or non-measurable lesion - Age ≥ 18 years - Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 - Good organ (hepatic, kidney, BM) function at screening/baseline visit. Exclusion Criteria: - Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy and anti-epileptic therapy. - Impaired cardiac function or clinically significant cardiac disease incl. unstable angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug. - Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control. Other protocol-defined inclusion/exclusion criteria may apply

Additional Information

Official title A Phase I Study of Oral MEK162 in Japanese Patients With Advanced Solid Tumors
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Array BioPharma.