A Study of ARRY-520 in Patients With Advanced Cancer

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).

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous; Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Marlene and Stewart Greenebaum Cancer Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University, Karmanos Cancer Institute

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARRY-520	Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous; Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
Experimental: ARRY-520 + G-CSF support	Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous; Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.; Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous; Part 1: standard of care; Part 2: standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF.	Part 1
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.	Part 1 and Part 2

Secondary Outcome Measures

Outcome Measure	Time Frame
Characterize the pharmacokinetics of the study drug.	Part 1 and Part 2
Assess the efficacy of the study drug in terms of tumor response.	Part 1 and Part 2

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2007
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: April 18, 2007
• First Submitted That Met QC Criteria: April 18, 2007
• First Posted (Estimate): April 19, 2007

Study Record Updates

• Last Update Posted (Actual): September 28, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Antimitotic Agents; Mitosis Modulators; Adjuvants, Immunologic; Lenograstim; Filanesib
• Other Study ID Numbers: ARRAY-520-101