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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT00959127

Public ClinicalTrials.gov record NCT00959127. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 5:36 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00959127
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
93 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 2009 (Type not available)
Primary completion
Jan 2013 (Actual)
Completion
Jan 2013 (Actual)
Last update posted
Sep 16, 2020

2009 – 2013

United States locations

U.S. sites
10
U.S. states
9
U.S. cities
10
Facility City State ZIP Site status
University of California, Los Angeles Los Angeles California 90095 —
University of Colorado Cancer Center Aurora Colorado 80045 —
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland 21231-1000 —
Dana-Farber/Harvard Cancer Center Boston Massachusetts 02114 —
University of Michigan Comprehensive Cancer Center Ann Arbor Michigan 48109 —
Washington University School of Medicine St Louis Missouri 63110 —
Ohio State University Columbus Ohio 43221 —
Sarah Cannon Research Institute Nashville Tennessee 37203 —
MD Anderson Cancer Center Houston Texas 77030 —
South Texas Accelerated Research Therapeutics San Antonio Texas 78229 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00959127, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 16, 2020 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00959127 live on ClinicalTrials.gov.

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