A Study of ARRY-142886 in Patients With Advanced Cancer

Array BioPharma

Status and phase

Completed

Phase 1

Conditions

Advanced Cancer

Treatments

Drug: ARRY-142886, MEK inhibitor; oral

Study type

Interventional

Funder types

Industry

Identifiers

NCT00085787

ARRY-0401

Details and patient eligibility

About

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).

Enrollment

57 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.