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| Sponsor: | Array BioPharma |
|---|---|
| Information provided by (Responsible Party): | Array BioPharma |
| ClinicalTrials.gov Identifier: | NCT00959127 |
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 |
| Estimated Enrollment: | 95 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (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 |
Key Inclusion Criteria (for Part 3):
Key Exclusion Criteria (for Part 3):
Contacts and 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 | |
More Information
| 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: | May 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Colorectal Adenocarcinoma Colon Cancer Rectal Cancer |
|
Colorectal Neoplasms Biliary Tract Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Biliary Tract Diseases |