Status:
COMPLETED
A Study of ARRY-380 in Patients With Advanced HER2+ Cancer
Lead Sponsor:
Seagen Inc.
Collaborating Sponsors:
Array BioPharma
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00650572
Start Date
May 1 2008
End Date
March 1 2013
Last Update
May 7 2020
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Colorado Cancer Center
Aurora, Colorado, United States
2
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77230
3
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
4
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9