A Study of ARRY-520 in Patients With Advanced Cancer

NCT ID: NCT00462358

Last Updated: 2020-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2010-11-30

Brief Summary

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).

Conditions

Advanced Solid Tumors

Study Design

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

Study Groups

ARRY-520

Group Type: EXPERIMENTAL

ARRY-520, KSP(Eg5) inhibitor; intravenous

Intervention Type: DRUG

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

ARRY-520 + G-CSF support

Group Type: EXPERIMENTAL

ARRY-520, KSP(Eg5) inhibitor; intravenous

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Part 1: standard of care; Part 2: standard of care.

Interventions

ARRY-520, KSP(Eg5) inhibitor; intravenous

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

Intervention Type: DRUG

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

Part 1: standard of care; Part 2: standard of care.

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• 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

Marlene and Stewart Greenebaum Cancer Center

Baltimore, Maryland, United States

Wayne State University, Karmanos Cancer Institute

Detroit, Michigan, United States

Countries

United States

Other Identifiers

ARRAY-520-101

Identifier Type: -

Identifier Source: org_study_id