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

NCT00959127 | Completed Phase 1

• 1 other identifier: ARRAY-162-111
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 10

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

Keywords

Colorectal Adenocarcinoma; Colon Cancer; Rectal Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (1)

ARRY-438162 (MEK 162)

EXPERIMENTAL

Drug: ARRY-438162 (MEK162), MEK inhibitor; oral

Interventions

ARRY-438162 (MEK162), MEK inhibitor; oral DRUG

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

ARRY-438162 (MEK 162)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Array Biopharma, now a wholly owned subsidiary of Pfizer: lead

Study Sites (10)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-1000, United States

Location

Dana-Farber/Harvard Cancer Center

Boston, Massachusetts, 02114, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Ohio State University

Columbus, Ohio, 43221, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

binimetinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2009
• First Posted: August 14, 2009
• Study Start: August 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

US (10)