A Phase I Study of Oral MEK162 in Japanese Patients With Advanced Solid Tumors

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2014

Interventions

  • Drug: MEK162
    • MEK162 in an oral formulation. It is a film-coated capsule-shape tablets (i.e. caplets).

Arms, Groups and Cohorts

  • Experimental: MEK162
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of Dose limiting toxicities
    • Time Frame: 4 weeks
    • Incidence of frequency of Dose limiting toxicities during first 4 weeks will be measured according to the commen terminology criteria for adverse events (CTCAE).

Secondary Measures

  • Incidence and severity of adverse events and serious adverse events, changes in laboratory values
    • Time Frame: 4 months
    • Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment.
  • Plasma concentration of MEK162 and AR00426032active metabolite of MEK162 and derived PK parameters of MEK162 and the active metabolite.
    • Time Frame: 2 months
    • Plasma concentration of MEK162 and active metabolite of MEK162 and derived PK parameters of MEK162 and the active metabolite will be measured with serial plasma samples during treatment for first 2 months.
  • Tumor responses according to RECIST 1.1
    • Time Frame: 4 months
    • Tumor responses will be measured according to RECIST 1.1
  • Levels of p-ERK in tumor and skin
    • Time Frame: 4 months
    • Levels of p-ERK in tumor during treatment and skin for first 2 weeks will be measured.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Array BioPharma
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Array BioPharma, Study Director, 303-381-6604

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.