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

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ClinicalTrials.gov Identifier: NCT01469130
Recruitment Status : Active, not recruiting
First Posted : November 10, 2011
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: MEK162 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Oral MEK162 in Japanese Patients With Advanced Solid Tumors
Study Start Date : November 2011
Primary Completion Date : April 2014
Estimated Study Completion Date : December 31, 2017
Arms and Interventions

Arm Intervention/treatment
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.

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


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. Tumor responses according to RECIST 1.1 [ Time Frame: 4 months ]
    Tumor responses will be measured according to RECIST 1.1

  4. 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469130


Locations
Japan
Array BioPharma Investigative Site
Nagoya-city, Aichi, Japan, 466-8560
Array BioPharma Investigative Site
Yufu, Oita, Japan, 879-5593
Sponsors and Collaborators
Array BioPharma
Investigators
Study Director: Array BioPharma 303-381-6604
More Information

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT01469130     History of Changes
Other Study ID Numbers: CMEK162X1101
First Posted: November 10, 2011    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by Array BioPharma:
MEK, Advanced solid tumor