A Study of ARRY-438162 (MEK162) in Patients With Advanced Cancer

This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-438162 (MEK162).

This study has 3 parts. In the first part, patients with advanced solid tumors will receive increasing doses of study drug in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1. (Active, not recruiting)

In the second part of the study, patients with advanced or metastatic biliary cancer will receive the best dose of study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 25 patients from the US will be enrolled in Part 2. (Active, not recruiting)

In the third part of the study, patients with metastatic colorectal cancer (CRC) will receive the best dose of the study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 25 patients with KRAS mutation (Active, not recruiting) and 15 patients with BRAF mutation (Active, not recruiting) from the US will be enrolled in Part 3.

Study Overview

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21231-1000
        • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Dana-Farber/Harvard Cancer Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Ohio State University
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria (for Part 3):

  • A histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma which is metastatic (measurable disease).
  • Documented KRAS- or BRAF- tumor mutation.
  • Previously treated with or unsuitable for treatment with 5-Fluorouracil (5-FU), oxaliplatin, irinotecan and, if available, bevacizumab.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  • Additional criteria exist.

Key Exclusion Criteria (for Part 3):

  • Uncontrolled or symptomatic brain metastases (if the patient has brain metastases and is on steroids, the steroid dose must have been stable for at least 30 days).
  • History of central serous retinopathy, retinopathy visible at baseline that would be considered a risk factor for central serous retinopathy or retinal vein occlusion.
  • Concomitant malignancies or previous malignancies with less than a 2-year disease free interval at the time of enrollment; patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or stage A low grade prostate cancer may enroll irrespective of the time of diagnosis.
  • Prior treatment with a MEK inhibitor.
  • Treatment with prior chemotherapy, anticancer immunotherapy, monoclonal antibodies or other protein or peptide therapeutics within 21 days of the first dose of study drug.
  • Treatment with a small molecule targeted agent or anticancer hormonal therapy within 14 days of the first dose of study drug.
  • Treatment with prior radiotherapy within 28 days of initiating study drug (if the radiation portal covered ≤ 10% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy).
  • Major surgery within 4 weeks or minor surgery within 7 days prior to the first dose of study drug.
  • Known positive serology for the human immunodeficiency virus (HIV), hepatitis C, and/or active hepatitis B.
  • Additional criteria exist.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARRY-438162 (MEK 162)
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Establish the maximum tolerated dose (MTD) of the study drug.
Time Frame: Part 1, one year
Part 1, one year
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time Frame: Parts 1, 2 and 3: two years
Parts 1, 2 and 3: two years
Characterize the pharmacokinetics (PK) of the study drug and metabolite.
Time Frame: Parts 1, 2 and 3: two years
Parts 1, 2 and 3: two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess the efficacy of the study drug in terms of tumor response, duration of response, duration of stable disease, progression-free survival and overall survival.
Time Frame: Parts 1, 2 and 3: two years
Parts 1, 2 and 3: two years
Assess possible PK/pharmacodynamic (PD) or PK/efficacy and safety correlations.
Time Frame: Parts 1, 2 and 3: two years
Parts 1, 2 and 3: two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

August 13, 2009

First Submitted That Met QC Criteria

August 13, 2009

First Posted (Estimate)

August 14, 2009

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 14, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • ARRAY-162-111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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