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

Pancreatic Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862524
• Other study ID #: ARRAY-543-206
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 16, 2009
• Last updated: September 28, 2012
• Start date: March 2009
• Est. completion date: February 2011

Study information

• Verified date: September 2012
• Source: Array BioPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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 Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• ARRY-334543, EGFR/ErbB2 inhibitor; oral
multiple dose, escalating
• Gemcitabine, nucleoside analogue; intravenous
multiple dose, single schedule

Locations

Country	Name	City	State
United States	University of Colorado Health Sciences Center	Aurora	Colorado
United States	Partners, Dana Farber	Boston	Massachusetts
United States	Partners, Massachusetts General Hospital	Boston	Massachusetts
United States	Sarah Cannon Research Center	Nashville	Tennessee
United States	Pinnacle Oncology/Hematology	Phoenix	Arizona
United States	Premiere Oncology	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Array BioPharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish the maximum tolerated dose (MTD) of study drug in combination with gemcitabine.		Part 1	Yes
Primary	Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.		Part 1	Yes
Primary	Characterize the pharmacokinetics (PK) of study drug, gemcitabine and a gemcitabine metabolite.		Part 1	No
Primary	Assess the efficacy of the study drug in combination with gemcitabine in terms of progression-free survival (PFS) at 16 weeks.		Part 2	No
Secondary	Assess the efficacy of the study drug in combination with gemcitabine in terms of tumor response.		Part 1	No
Secondary	Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.		Part 2	Yes