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Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer

This study is currently recruiting participants.
Verified March 2013 by Medivation, Inc.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT01597193
First received: May 9, 2012
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to determine the safety and tolerability of enzalutamide in patients with incurable breast cancer.


Condition Intervention Phase
Breast Cancer
 Drug: enzalutamide
 Phase 1

Study Type: Interventional
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.


Estimated Enrollment: 50
Study Start Date: April 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enzalutamide
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.
 Drug: enzalutamide
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597193

Contacts
Contact: Amy Peterson, MD 415-983-3018 amy.peterson@medivation.com
Contact: Erich Mynock 415-432-4170 erich.mynock@medivation.com

Locations
United States, Colorado
Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Recruiting
Sarasota, Florida, United States, 34232
United States, Michigan
Recruiting
Detroit, Michigan, United States, 48201
United States, New York
Recruiting
New York, New York, United States, 10065
United States, Tennessee
Recruiting
Memphis, Tennessee, United States, 38120
Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Medivation, Inc.
Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT01597193     History of Changes
Other Study ID Numbers: MDV3100-08
Study First Received: May 9, 2012
Last Updated: March 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medivation, Inc.:
enzalutamide
MDV3100
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013