NCT00862524

A Study of ARRY-334543 and Gemcitabine in Patients With Advanced Cancer and Pancreatic Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Array BioPharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 2-phase study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and gemcitabine. The study has 2 parts. In the first part of the study, Phase 1, patients with advanced/metastatic solid tumors will receive increasing doses of study drug in combination with gemcitabine in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 24 patients from the US will be enrolled in Part 1 (Completed). In the second part of the study, Phase 2, patients with metastatic pancreatic cancer will receive the best dose of study drug, in combination with gemcitabine, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).

Conditions

• Advanced Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	ARRY-334543, EGFR/ErbB2 inhibitor; oral	multiple dose, escalating
DRUG	Gemcitabine, nucleoside analogue; intravenous	multiple dose, single schedule

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2009-03-17
• Last updated: 2012-10-04

Locations

6 sites across 1 country: United States