Who is sponsoring NCT00959127?

NCT00959127 is sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.

What condition does NCT00959127 study?

NCT00959127 studies Advanced Solid Tumors, Advanced or Metastatic Biliary Cancer, Metastatic Colorectal Cancer.

What drugs are being tested in NCT00959127?

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

What is the status of NCT00959127?

NCT00959127 is currently COMPLETED.

Last reviewed 2020-09-14 · How we verify

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

NCT00959127 Phase 1 COMPLETED

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.

Details

Lead sponsor	Array Biopharma, now a wholly owned subsidiary of Pfizer
Phase	Phase 1
Status	COMPLETED
Enrolment	93
Start date	2009-08
Completion	2013-01

Conditions

Advanced Solid Tumors
Advanced or Metastatic Biliary Cancer
Metastatic Colorectal Cancer

Interventions

ARRY-438162 (MEK162), MEK inhibitor; oral

Primary outcomes

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

Countries

United States