A Study of ARRY-380 in Patients With Advanced HER2+ Cancer - Full Text View

Purpose

This is a Phase 1 study during which patients with advanced HER2+ solid malignancies or HER2+ metastatic breast cancer will receive investigational study drug ARRY-380.

This study has 2 parts. In the first part, patients with advanced HER2+ solid malignancies, who have already received at least one previous standard therapy, will receive increasing doses of study drug in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1 (Completed).

In the second part of this study, patients with HER2+ metastatic breast cancer, who have already received at least one previous standard therapy, will receive the best dose of study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 20 patients from the US will be enrolled in Part 2 (Active, not recruiting).

Condition	Intervention	Phase
Cancer	Drug: ARRY-380, HER2 inhibitor; oral	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Array BioPharma:

Primary Outcome Measures:

Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Part 1, one year; Part 2, one year ] [ Designated as safety issue: Yes ]
Establish the maximum tolerated dose (MTD) of the study drug. [ Time Frame: Part 1, one year ] [ Designated as safety issue: Yes ]
Characterize the pharmacokinetics of the study drug. [ Time Frame: Part 2, one year ] [ Designated as safety issue: No ]
Assess amplification/expression of HER2 in archival and tumor tissues. [ Time Frame: Part 2, one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Characterize the pharmacokinetics of the study drug. [ Time Frame: Part 1, one year ] [ Designated as safety issue: No ]
Assess changes in tumor markers. [ Time Frame: Part 1, one year ] [ Designated as safety issue: No ]
Assess the efficacy of study drug in terms of tumor response and duration of response. [ Time Frame: Part 1, one year; Part 2, one year ] [ Designated as safety issue: No ]
Assess expression of growth factor pathway proteins in archival and tumor tissues. [ Time Frame: Part 2, one year ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	May 2008
Study Completion Date:	March 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ARRY-380	Drug: ARRY-380, HER2 inhibitor; oral Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria (Part 1 and Part 2):

Histological or cytological evidence of HER2+ cancer (Part 1) or HER2+ metastatic breast cancer (Part 2).
Patients should have received at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy (patients with HER2+ breast cancer and with clinical indication for trastuzumab or lapatinib should have received prior therapy with trastuzumab and lapatinib, if available).
Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0 and 2.
Additional criteria exist.

Key Exclusion Criteria (Part 1 and Part 2):

Uncontrolled or symptomatic brain metastases (patients may be considered adequately controlled if on a stable steroid dose for at least 30 days).
Treatment with an investigational medicinal product or device within 30 days prior to first dose of study drug.
Radiotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).
Chemotherapy within 21 days prior to first dose of study drug.
Major surgery within 30 days prior to first dose of study drug.
Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or active hepatitis C.
Additional criteria exist.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650572

Locations

United States, Colorado
The University of Colorado Cancer Center
Aurora, Colorado, United States
United States, Texas
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77230
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9

Sponsors and Collaborators

Array BioPharma

More Information

No publications provided

Responsible Party:	Array BioPharma
ClinicalTrials.gov Identifier:	NCT00650572 History of Changes
Other Study ID Numbers:	ARRAY-380-101
Study First Received:	March 31, 2008
Last Updated:	March 6, 2013
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

Keywords provided by Array BioPharma:

human epidermal growth factor receptor 2
epidermal growth factor receptor
EGFR
type I receptor tyrosine kinase

ClinicalTrials.gov processed this record on May 22, 2013