NCT00278902

A Study of ARRY-334543 in Patients With Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (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-334543. This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 70 patients from the US and Canada will be enrolled in Part 1 (Completed). In the second part of the study, patients will receive the best dose(s) and schedule(s) of study drug determined from the first part of the study and will be followed to see what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 40 patients from the US and Canada will be enrolled in Part 2 (Completed).

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DRUG	ARRY-334543, EGFR/ErbB2 inhibitor; oral	Part 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule

Timeline

• Start date: 2006-01-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2006-01-19
• Last updated: 2020-10-14

Locations

5 sites across 2 countries: United States, Canada