A Study of ARRY-520 in Patients With Advanced Cancer

Phase 1

Completed

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

• Registration Number: NCT00462358
• Lead Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-18
• Study First Submitted QC: 2007-04-18
• Study First Posted: 2007-04-19
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-24
• Last Update Posted: 2020-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARRY-520 + G-CSF support	ARRY-520, KSP(Eg5) inhibitor; intravenous	-
ARRY-520 + G-CSF support	Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous	-
ARRY-520	ARRY-520, KSP(Eg5) inhibitor; intravenous	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Assess the efficacy of the study drug in terms of tumor response.	Part 1 and Part 2
Characterize the pharmacokinetics of the study drug.	Part 1 and Part 2

Trial Locations

Locations (2)

Marlene and Stewart Greenebaum Cancer Center; 🇺🇸 Baltimore, Maryland, United States

Wayne State University, Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States