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

NCT ID: NCT00650572

Last Updated: 2020-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2013-03-31

Brief Summary

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).

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARRY-380

Group Type: EXPERIMENTAL

ARRY-380, HER2 inhibitor; oral

Intervention Type: DRUG

Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.

Interventions

ARRY-380, HER2 inhibitor; oral

Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Array BioPharma

INDUSTRY

Sponsor Role: collaborator

Seagen Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Colorado Cancer Center

Aurora, Colorado, United States

The University of Texas, MD Anderson Cancer Center

Houston, Texas, United States

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, Canada

Countries

United States; Canada

Other Identifiers

ARRAY-380-101

Identifier Type: -

Identifier Source: org_study_id