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

Sponsor

Array BioPharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00862524

Collaborator

(none)

Enrollment

Locations

Arm

23.1

Duration (Months)

3.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancer Pancreatic Cancer	Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral Drug: Gemcitabine, nucleoside analogue; intravenous	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pinnacle Oncology/Hematology	Phoenix	Arizona	United States	85258
2	Premiere Oncology	Santa Monica	California	United States	90404-2111
3	University of Colorado Health Sciences Center	Aurora	Colorado	United States	80045
4	Partners, Massachusetts General Hospital	Boston	Massachusetts	United States	02114
5	Partners, Dana Farber	Boston	Massachusetts	United States	02115
6	Sarah Cannon Research Center	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

Array BioPharma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Array BioPharma

ClinicalTrials.gov Identifier:

NCT00862524

Other Study ID Numbers:

ARRAY-543-206

First Posted:

Mar 17, 2009

Last Update Posted:

Oct 4, 2012

Last Verified:

Sep 1, 2012

Additional relevant MeSH terms:

Pancreatic Neoplasms

Gemcitabine

Study Results

No Results Posted as of Oct 4, 2012