You are here

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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
ATTN-Research Pharmacist
Aurora, Colorado, 80045 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01597193
Pfizer
Completed
Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Renal Cell Cancer
NCT02684006
All Genders
18+
Years
Multiple Sites
Non-Small Cell Lung Cancer
NCT02349633
All Genders
18+
Years
Multiple Sites
Advanced Breast Cancer, Metastatic Breast Cancer
NCT03280303
All Genders
18+
Years
Multiple Sites
Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer
A Phase 1 Open-label, Dose Escalation Study Evaluating The Safety, Tolerability, And Pharmacokinetics Of Enzalutamide (Formerly Mdv3100) In Patients With Incurable Breast Cancer
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • 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
  • Drug: exemestane
    The exemestane dose is 25mg daily.
    Other Name: Aromasin
  • Drug: fulvestrant
    500 mg every 28 days
    Other Name: Faslodex
  • 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 (80-mg with increase to 160 mg)
    enzalutamide be provided as two or four 40-mg capsules by mouth daily
    Intervention: Drug: enzalutamide
  • 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.
    Interventions:
    • Drug: anastrozole
    • Drug: enzalutamide
  • 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
    Interventions:
    • Drug: exemestane
    • Drug: enzalutamide
  • 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
    Interventions:
    • Drug: enzalutamide
    • Drug: exemestane
  • 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
    Interventions:
    • Drug: fulvestrant
    • Drug: enzalutamide
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
101
December 2017
December 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01597193
MDV3100-08
C3431006 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
  • Astellas Pharma Inc
  • Medivation, Inc.
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer
Pfizer
October 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now