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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 2, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in patients with incurable breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: enzalutamide
Drug: anastrozole
Drug: exemestane
Drug: fulvestrant
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 Enzalutamide (Formerly MDV3100) in Patients With Incurable Breast Cancer

Resource links provided by NLM:


Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of daily enzalutamide [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    • To evaluate the safety, tolerability, and dose-limiting toxicities (DLTs) of enzalutamide in patients with incurable (Stage IV, or locally advanced unresectable) breast cancer;
    • To evaluate the safety and tolerability of daily enzalutamide at the recommended Phase 2 dose in patients with incurable androgen receptor positive (AR+) breast cancer.

  • To evaluate the safety and tolerability of daily enzalutamide plus anastrozole [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • To evaluate the safety and tolerability of daily enzalutamide plus exemestane 25 mg/day [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • To evaluate the safety and tolerability of daily enzalutamide plus exemestane 50 mg/day [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • To evaluate the safety and tolerability of daily enzalutamide plus fulvestrant [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize the pharmacokinetic properties of enzalutamide [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • To characterize the pharmacokinetic properties of enzalutamide plus anastrozole [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • To characterize the pharmacokinetic properties of enzalutamide plus exemestane [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: enzalutamide (80-mg with increase to 160 mg)
enzalutamide be provided as two or four 40-mg capsules by mouth daily
Drug: enzalutamide
80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.
Other Name: MDV3100, Xtandi
Experimental: enzalutamide and anastrozole
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with anastrozole (1 mg) administered as one 1-mg tablet by mouth once daily.
Drug: enzalutamide
80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.
Other Name: MDV3100, Xtandi
Drug: anastrozole
1 mg/day
Other Name: Arimidex
Experimental: enzalutamide and exemestane 25 mg
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with exemestane administered as one 25-mg tablet daily
Drug: enzalutamide
80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.
Other Name: MDV3100, Xtandi
Drug: exemestane
The 2 exemestane doses are 25mg daily and 50 mg daily
Other Name: Aromasin
Experimental: enzalutamide and exemestane 50 mg
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with exemestane administered as two 25-mg tablets daily
Drug: enzalutamide
80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.
Other Name: MDV3100, Xtandi
Drug: exemestane
The 2 exemestane doses are 25mg daily and 50 mg daily
Other Name: Aromasin
Experimental: enzalutamide and fulvestrant
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with fulvestrant (500 mg) administered as two 250-mg intramuscular injections every 28 days
Drug: enzalutamide
80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.
Other Name: MDV3100, Xtandi
Drug: fulvestrant
500 mg every 28 days
Other Name: Faslodex

  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 (for enzalutamide alone arm only);
  • 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;
  • For patients who are enrolled to receive enzalutamide plus anastrozole or exemestane or fulvestrant must not have received tamoxifen or any medication known to be a potent CYP3A4 inducer or inhibitor.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597193

Contacts
Contact: Jane Denison 1-855-349-1891 breastcancertrials@medivation.com

Locations
United States, Colorado
Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Recruiting
Sarasota, Florida, United States, 34232
United States, Michigan
Completed
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: September 2, 2014
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
Fulvestrant
Anastrozole
Exemestane
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014