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

Phase 1

Completed

• Conditions: Advanced Cancer; Pancreatic Cancer
• Interventions: Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral; Drug: Gemcitabine, nucleoside analogue; intravenous

• Registration Number: NCT00862524
• Lead Sponsor: Array BioPharma

Brief 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 Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-16
• Study First Submitted QC: 2009-03-16
• Study First Posted: 2009-03-17
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Disposition First Submitted: 2012-01-23
• Disposition First Submitted QC: 2012-01-23
• Disposition First Posted: 2012-01-27
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-28
• Last Update Posted: 2012-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARRY-334543 + gemcitabine	ARRY-334543, EGFR/ErbB2 inhibitor; oral	-
ARRY-334543 + gemcitabine	Gemcitabine, nucleoside analogue; intravenous	-

Primary Outcome Measures

Name	Time	Method
Establish the maximum tolerated dose (MTD) of study drug in combination with gemcitabine.	Part 1
Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.	Part 1
Characterize the pharmacokinetics (PK) of study drug, gemcitabine and a gemcitabine metabolite.	Part 1
Assess the efficacy of the study drug in combination with gemcitabine in terms of progression-free survival (PFS) at 16 weeks.	Part 2

Secondary Outcome Measures

Name	Time	Method
Assess the efficacy of the study drug in combination with gemcitabine in terms of tumor response.	Part 1
Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.	Part 2

Trial Locations

Locations (6)

Pinnacle Oncology/Hematology; 🇺🇸 Phoenix, Arizona, United States

Premiere Oncology; 🇺🇸 Santa Monica, California, United States

University of Colorado Health Sciences Center; 🇺🇸 Aurora, Colorado, United States

Partners, Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Partners, Dana Farber; 🇺🇸 Boston, Massachusetts, United States

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