A Study of ARRY-520 in Patients With Advanced Cancer

Array BioPharma

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous

Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous

Study type

Interventional

Funder types

Industry

Identifiers

NCT00462358

ARRAY-520-101

Details and patient eligibility

About

This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-520.

This study has two parts. In the first part, patients with advanced solid tumors will receive increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF) support, in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 15 patients (per schedule) 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 evaluate what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 15 patients from the US will be enrolled in Part 2 (Completed).

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Histological or cytological evidence of malignancy.
Advanced solid tumors that have recurred or progressed following standard therapy(ies).
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
Adequate hematology counts and serum chemistry values.
Additional criteria exist.

Key Exclusion Criteria:

Treatment with an investigational product or device, or anti-neoplastic therapy (with the exclusion of hormone therapy where the therapy will continue at a standard dose throughout the study) within 28 days prior to the first dose of study drug.
Major surgery within 28 days prior to the first dose of study drug.
Radiotherapy (RT) within 28 days prior to the first dose of study drug (except if local RT to <5% of the bone marrow).
Known positive serology for the human immunodeficiency virus (HIV), hepatitis C, and/or active hepatitis B.
Additional criteria exist.