A Study of ARRY-142886 in Patients With Advanced Cancer

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).

Study Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Drug: ARRY-142886, MEK inhibitor; oral

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80010
      • University of Colorado Cancer Center, Anschutz Cancer Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria (Part 2):

• Histopathologically or cytologically confirmed solid tumor that is refractory to standard therapies, or for which no standard therapies exist, or for which the Investigator feels no other active therapy is required for the duration of the study.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
• Estimated life expectancy of greater than or equal to 3 months.
• Patient must have a tumor that is accessible for biopsy and must consent to paired tumor biopsies and normal skin biopsies being taken pre- and post-dose of study drug.
• Additional criteria exist.

Key Exclusion Criteria (Part 2):

• Uncontrolled or symptomatic brain metastases.
• Use of investigational drug or device within 30 days prior to first dose of study drug.
• Major surgery within 30 days prior to study start.
• Radiotherapy or chemotherapy within 21 days prior to study start (not including palliative radiotherapy at focal sites).
• Pregnancy or lactation.
• Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
• Additional criteria exist.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARRY-142886	Drug: ARRY-142886, MEK inhibitor; oral; Part 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): February 1, 2007
• Study Completion (Actual): February 1, 2007

Study Registration Dates

• First Submitted: June 14, 2004
• First Submitted That Met QC Criteria: June 16, 2004
• First Posted (Estimate): June 17, 2004

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ARRY-0401