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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT01597193
First received: May 9, 2012
Last updated: March 15, 2016
Last verified: March 2016
  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 ]
  • To characterize the pharmacokinetic properties of enzalutamide plus fulvestrant [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: April 2012
Estimated Study Completion Date: December 2016
Primary Completion Date: December 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: anastrozole
1 mg/day
Other Name: Arimidex
Drug: enzalutamide
160 mg (4 capsules) taken orally daily.
Other Names:
  • MDV3100
  • Xtandi
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: exemestane
The exemestane dose is 25mg daily.
Other Name: Aromasin
Drug: enzalutamide
160 mg (4 capsules) taken orally daily.
Other Names:
  • MDV3100
  • Xtandi
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
160 mg (4 capsules) taken orally daily.
Other Names:
  • MDV3100
  • Xtandi
Drug: exemestane
The exemestane dose is 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: fulvestrant
500 mg every 28 days
Other Name: Faslodex
Drug: enzalutamide
160 mg (4 capsules) taken orally daily.
Other Names:
  • MDV3100
  • Xtandi

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Locations
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
Medivation, Inc.
Astellas Pharma Inc
Investigators
Study Director: Medical Director Medivation, Inc.
  More Information

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 15, 2016
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
Estradiol
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Hormones
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2016