A Study of ARRY-334543 in Patients With Advanced Cancer

Phase 1

Completed

• Conditions: Advanced Cancer
• Interventions: Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral

• Registration Number: NCT00278902
• 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-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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-17
• Study First Submitted QC: 2006-01-17
• Study First Posted: 2006-01-19
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-12
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARRY-334543	ARRY-334543, EGFR/ErbB2 inhibitor; oral	-

Primary Outcome Measures

Name	Time	Method
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.	Part 1 and Part 2
Establish the maximum tolerated dose (MTD) of study drug.	Part 1

Secondary Outcome Measures

Name	Time	Method
Assess the efficacy of the study drug in terms of tumor dimension assessment.	Part 1 and Part 2
Characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentrations.	Part 1 and Part 2

Trial Locations

Locations (5)

British Columbia Cancer Agency; 🇨🇦 Vancouver, British Columbia, Canada

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

British Columbia Cancer Agency- Centre for the Southern Interior; 🇨🇦 Kelowna, British Columbia, Canada

Sarah Cannon Research Center; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States