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

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NCT01597193

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Study Location
ATTN-Research Pharmacist
Aurora, Colorado, 80045, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer
Official Title  ICMJE A PHASE 1 OPEN-LABEL, DOSE ESCALATION STUDY EVALUATING THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF ENZALUTAMIDE (FORMERLY MDV3100) IN PATIENTS WITH INCURABLE BREAST CANCER
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2015)		101
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2012)		27
Actual Study Completion Date  ICMJE January 22, 2018
Actual Primary Completion Date December 15, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01597193
Other Study ID Numbers  ICMJE MDV3100-08
C3431006 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE
  • Astellas Pharma Inc
  • Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Investigators  ICMJE
Study Director:Pfizer Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP