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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01597193
First Posted: May 11, 2012
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Astellas Pharma Inc
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer
  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
Masking: None (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 Pfizer:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of daily enzalutamide [ Time Frame: 18 months ]
    • 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 ]
  • To evaluate the safety and tolerability of daily enzalutamide plus exemestane 25 mg/day [ Time Frame: 18 months ]
  • To evaluate the safety and tolerability of daily enzalutamide plus exemestane 50 mg/day [ Time Frame: 18 months ]
  • To evaluate the safety and tolerability of daily enzalutamide plus fulvestrant [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • To characterize the pharmacokinetic properties of enzalutamide [ Time Frame: 5 months ]
  • To characterize the pharmacokinetic properties of enzalutamide plus anastrozole [ Time Frame: 5 months ]
  • To characterize the pharmacokinetic properties of enzalutamide plus exemestane [ Time Frame: 5 months ]
  • To characterize the pharmacokinetic properties of enzalutamide plus fulvestrant [ Time Frame: 5 months ]

Enrollment: 101
Actual Study Start Date: April 2012
Estimated Study Completion Date: December 2017
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597193


Locations
United States, Colorado
ATTN-Research Pharmacist
Aurora, Colorado, United States, 80045
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
University of Colorado Hospital, Anschutz Outpatient Pavilion
Aurora, Colorado, United States, 80045
United States, Connecticut
Connecticut Multispecialty Group
Enfield, Connecticut, United States, 06082
United States, Florida
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Mississippi
The West Clinic
Corinth, Mississippi, United States, 38834
The West Clinic
Southaven, Mississippi, United States, 38671
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10022
Memorial Sloan Kettering Cancer Center - IDS Pharmacy
New York, New York, United States, 10065
Memorial Sloan Kettering Cancer Center - OPD Pharmacy
New York, New York, United States, 10065
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38104
The West Clinic
Memphis, Tennessee, United States, 38120
Tennessee Oncology, PLLC.
Nashville, Tennessee, United States, 37203
The Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Pfizer
Astellas Pharma Inc
Medivation, Inc.
Investigators
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer
  More Information

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01597193     History of Changes
Other Study ID Numbers: MDV3100-08
C3431006 ( Other Identifier: Alias Study Number )
First Submitted: May 9, 2012
First Posted: May 11, 2012
Last Update Posted: October 31, 2017
Last Verified: October 2017

Keywords provided by Pfizer:
enzalutamide
MDV3100
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Anastrozole
Exemestane
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action