NCT00462358

A Study of ARRY-520 in Patients With Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-04-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2007-04-19
• Last updated: 2020-09-28

Locations

2 sites across 1 country: United States