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

NCT ID: NCT00959127

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-01-31

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.

Conditions

Advanced Solid Tumors; Advanced or Metastatic Biliary Cancer; Metastatic Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARRY-438162 (MEK 162)

Group Type: EXPERIMENTAL

ARRY-438162 (MEK162), MEK inhibitor; oral

Intervention Type: DRUG

Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.

Interventions

ARRY-438162 (MEK162), MEK inhibitor; oral

Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Array Biopharma, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

University of California, Los Angeles

Los Angeles, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Dana-Farber/Harvard Cancer Center

Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Ohio State University

Columbus, Ohio, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Countries

United States

Other Identifiers

ARRAY-162-111

Identifier Type: -

Identifier Source: org_study_id