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

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 Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85258
      • Pinnacle Oncology/Hematology
  • California
    • Santa Monica, California, United States, 90404-2111
      • Premiere Oncology
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Health Sciences Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Partners, Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Partners, Dana Farber
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria (Part 1):

• Histologically or cytologically confirmed diagnosis of a solid tumor suitable for treatment with gemcitabine.
• No more than 3 prior anticancer regimens for advanced disease.
• Measurable or evaluable, nonmeasurable disease.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
• Able to take and retain oral medications.
• Additional criteria exist.

Key Exclusion Criteria (Part 1):

• Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must have been stable for at least 30 days).
• Treatment with prior chemotherapy within 21 days of first dose of study drug.
• Requiring IV alimentation.
• Pregnancy or lactation.
• Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
• History of being unable to tolerate gemcitabine or any of its components.
• Additional criteria exist.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARRY-334543 + gemcitabine	Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral; multiple dose, escalating; Drug: Gemcitabine, nucleoside analogue; intravenous; multiple dose, single schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Array BioPharma

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: March 16, 2009
• First Submitted That Met QC Criteria: March 16, 2009
• First Posted (Estimate): March 17, 2009

Study Record Updates

• Last Update Posted (Estimate): October 4, 2012
• Last Update Submitted That Met QC Criteria: September 28, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine
• Other Study ID Numbers: ARRAY-543-206