A Study of ARRY-380 in Patients With Advanced HER2+ Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/29/2018 |
| Start Date: | May 2008 |
| End Date: | March 2013 |
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).
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).
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.
We found this trial at
3
sites
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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