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A Phase 1 Open-Label, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of MDV3100 in Patients With Incurable Breast Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

A Phase 1 Open-Label, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of MDV3100 in Patients With Incurable Breast Cancer


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;

- 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;

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety, tolerability of daily enzalutamide

Outcome Description:

The parameters describing the safety and tolerability of MDV3100 will include: The percentage of patients with DLTs; The percentage of patients with adverse events by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) (version 4.03) grade and associated dose of MDV3100; The percentage of patients with serious adverse events; The percentage of patients who discontinue MDV3100 due to adverse events or serious adverse events; The percentage of patients who require dose modifications (reductions or cessation) of MDV3100.

Outcome Time Frame:

12 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

MDV3100-08

NCT ID:

NCT01597193

Start Date:

April 2012

Completion Date:

October 2013

Related Keywords:

  • Breast Cancer
  • enzalutamide
  • MDV3100
  • breast cancer
  • Breast Neoplasms

Name

Location
Miami, Florida  33176
Albany, New York  12208
Nashville, Tennessee  37203-1632
Flint, Michigan  48532
Denver, Colorado