A Phase 1 Open-Label, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of MDV3100 in Patients With Incurable Breast Cancer
18 Years
N/A
Both
Breast Cancer
Trial Information
A Phase 1 Open-Label, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of MDV3100 in Patients With Incurable Breast Cancer
Inclusion Criteria:
- Histologically confirmed breast cancer with accompanying pathology report;
- Submit unstained representative tumor specimen, either as a paraffin block
(preferred) or ≥ 10 unstained slides
- Received at least 2 lines of systemic therapy in the advanced setting;
- Eastern Cooperative Oncology Group performance (ECOG) status of 0 or 1;
- Estimated life expectancy of at least 3 months
Exclusion Criteria:
- Severe concurrent disease, infection, or comorbidity that, in the judgment of the
Investigator, would make the patient inappropriate for enrollment;
- Pregnant or lactating;
- Known or suspected brain metastasis or leptomeningeal disease;
- History of another malignancy within the previous 5 years other than curatively
treated in situ carcinomas;
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the safety, tolerability of daily enzalutamide
Outcome Description:
The parameters describing the safety and tolerability of MDV3100 will include: The percentage of patients with DLTs; The percentage of patients with adverse events by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) (version 4.03) grade and associated dose of MDV3100; The percentage of patients with serious adverse events; The percentage of patients who discontinue MDV3100 due to adverse events or serious adverse events; The percentage of patients who require dose modifications (reductions or cessation) of MDV3100.
Outcome Time Frame:
12 months
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
MDV3100-08
NCT ID:
NCT01597193
Start Date:
April 2012
Completion Date:
October 2013
Related Keywords:
- Breast Cancer
- enzalutamide
- MDV3100
- breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Miami, Florida 33176 | |
| Albany, New York 12208 | |
| Nashville, Tennessee 37203-1632 | |
| Flint, Michigan 48532 | |
| Denver, Colorado |
