Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer
This study is currently recruiting participants.
Verified November 2013 by Medivation, Inc.
Astellas Pharma Inc
Information provided by (Responsible Party):
First received: May 9, 2012
Last updated: November 18, 2013
Last verified: November 2013
The purpose of this study is to determine the safety and tolerability of enzalutamide in patients with incurable breast cancer.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Open-Label, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of MDV3100 in Patients With Incurable Breast Cancer|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Medivation, Inc.:
Primary Outcome Measures:
- To evaluate the safety, tolerability of daily enzalutamide [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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.
Secondary Outcome Measures:
- To characterize the pharmacokinetic properties of enzalutamide [ Time Frame: 12 months ] [ Designated as safety issue: No ]Individual and mean plasma concentration time data after single and multiple-dose administration will be tabulated and displayed by dose level and analyzed by noncompartmental methods to obtain the following key parameters: Cmax, tmax, AUC, t1/2, CL/F, V/F, peak-to-trough, dose proportionality, and accumulation.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Enzalutamide, with the chemical name 3-(4-cyano-3- trifluoromethylphenyl)-1-[3-fluoro-4-(methylcarbamoyl) phenyl]-5,5-dimethyl-2-thioxoimidazolin-4-one, will be provided as 40 mg soft gelatin capsules.
The proposed enzalutamide doses for Stage 1 (Dose Escalation) are 80 mg (2 capsules) and 160 mg (4 capsules)taken orally daily. The dose for Stage 2 (Dose Expansion) will be determined in Stage 1.
Other Name: MDV3100
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597193
|Contact: Jane Denisonfirstname.lastname@example.org|
|United States, Colorado|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|Sarasota, Florida, United States, 34232|
|United States, Michigan|
|Detroit, Michigan, United States, 48201|
|United States, New York|
|New York, New York, United States, 10065|
|United States, Tennessee|
|Memphis, Tennessee, United States, 38120|
|Nashville, Tennessee, United States, 37203|
Sponsors and Collaborators
Astellas Pharma Inc