A Study of ARRY-142886 in Patients With Advanced Cancer

Phase 1

Completed

• Conditions: Advanced Cancer
• Interventions: Drug: ARRY-142886, MEK inhibitor; oral

• Registration Number: NCT00085787
• Lead Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer

Brief Summary

This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-142886.

This study has 2 parts. In the first part, patients will receive increasing doses of study drug in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 25 patients from the US will be enrolled in Part 1 (Completed).

In the second part of the study, patients 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 the study drug causes and what effectiveness the study drug has, if any, in treating the cancer. Approximately 35 patients from the US will be enrolled in Part 2 (Completed).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2004-06-14
• Study First Submitted QC: 2004-06-16
• Study First Posted: 2004-06-17
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-12
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARRY-142886	ARRY-142886, MEK inhibitor; oral	-

Primary Outcome Measures

Name	Time	Method
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.	Part 1
Establish the maximum tolerated dose (MTD) of study drug.	Part 1
Assess the biological activity of the study drug in tumors in terms of inhibition of extracellular signal-regulated kinase (ERK) phosphorylation.	Part 2

Secondary Outcome Measures

Name	Time	Method
Characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentrations.	Part 1 and Part 2
Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.	Part 1 and Part 2
Assess the efficacy of the study drug in terms of tumor dimension assessment.	Part 1 and Part 2
Confirm the safety of the study drug at the MTD as determined by adverse events, clinical laboratory tests, vital signs and electrocardiograms.	Part 2

Trial Locations

Locations (3)

University of Colorado Cancer Center, Anschutz Cancer Center; 🇺🇸 Aurora, Colorado, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States