An Open-Label, Phase I Study of ARN-810 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
Open-label, dose-finding study of ARN-810 administered orally on a continuous daily dosing
regimen with a PK lead-in period . The incidence of dose limiting toxicity (DLT) will be
evaluated from Day -7 through the first cycle (28 days) of treatment (35 days total).
Depending on safety and tolerability, patients will be assigned sequentially to escalating
doses of ARN 810 using standard 3+3 design. All patients will be treated until disease
progression, unacceptable toxicity, or patient withdrawal of consent.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of ARN-810 in postmenopausal women with locally advanced or metastatic ER+ (HER2-) breast cancer
Edna Chow Maneval, PhD
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|