A Study of ARRY-142886 in Patients With Advanced Cancer

NCT ID: NCT00085787

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2007-02-28

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).

Conditions

Advanced Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARRY-142886

Group Type: EXPERIMENTAL

ARRY-142886, MEK inhibitor; oral

Intervention Type: DRUG

Part 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule

Interventions

ARRY-142886, MEK inhibitor; oral

Part 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Array Biopharma, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

University of Colorado Cancer Center, Anschutz Cancer Center

Aurora, Colorado, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

ARRY-0401

Identifier Type: -

Identifier Source: org_study_id