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

Phase 1

Completed

• Conditions: Advanced Solid Tumors; Advanced or Metastatic Biliary Cancer; Metastatic Colorectal Cancer
• Interventions: Drug: ARRY-438162 (MEK162), MEK inhibitor; oral

• Registration Number: NCT00959127
• Lead Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-13
• Study First Posted: 2009-08-14
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARRY-438162 (MEK 162)	ARRY-438162 (MEK162), MEK inhibitor; oral	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	Parts 1, 2 and 3: two years
Assess possible PK/pharmacodynamic (PD) or PK/efficacy and safety correlations.	Parts 1, 2 and 3: two years

Trial Locations

Locations (10)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

South Texas Accelerated Research Therapeutics; 🇺🇸 San Antonio, Texas, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

University of Colorado Cancer Center; 🇺🇸 Aurora, Colorado, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Dana-Farber/Harvard Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States