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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT00959127
First received: August 13, 2009
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Advanced Solid Tumors
Advanced or Metastatic Biliary Cancer
Metastatic Colorectal Cancer
Drug: ARRY-438162 (MEK162), MEK inhibitor; oral
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • Establish the maximum tolerated dose (MTD) of the study drug. [ Time Frame: Part 1, one year ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Characterize the pharmacokinetics (PK) of the study drug and metabolite. [ Time Frame: Parts 1, 2 and 3: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Assess possible PK/pharmacodynamic (PD) or PK/efficacy and safety correlations. [ Time Frame: Parts 1, 2 and 3: two years ] [ Designated as safety issue: No ]

Enrollment: 93
Study Start Date: August 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARRY-438162 (MEK 162) Drug: ARRY-438162 (MEK162), MEK inhibitor; oral
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959127

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

No publications provided

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00959127     History of Changes
Other Study ID Numbers: ARRAY-162-111
Study First Received: August 13, 2009
Last Updated: February 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Array BioPharma:
Colorectal Adenocarcinoma
Colon Cancer
Rectal Cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 19, 2014