Study of ARN-810 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
Safety and pharmacokinetics (PK) study of ARN-810 in postmenopausal women with locally advanced or metastatic ER+ (HER2-) breast cancer.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Phase I Study of ARN-810 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer|
- Maximum Tolerated Dose (MTD) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]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
- To determine the safety of ARN-810 and its O-glucuronide metabolite in postmenopausal women with locally advanced or metastatic ER+ (HER2-) breast cancer [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Incidence of treatment-emergent adverse events will be summarized by severity and relationship to study drug. Clinical laboratory results, vital signs, use of concomitant medications and treatments, and endometrial thickness will be summarized with descriptive statistics (such as mean, median, standard deviation and range for continuous data, and percentages for categorical data).
- Pharmacokinetics (PK) of ARN-810 and its O-glucuronide metabolite [ Time Frame: 12 months ] [ Designated as safety issue: No ]Full plasma PK profiles (Cmax, Tmax, AUC, T1/2) will be obtained for ARN-810 and its O-glucuronide metabolite and analyzed using non-compartmental methods.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
During dose escalation, standard 3+3 design will be followed with a starting dose of 100 mg per day, followed by dose escalation to 200 mg, and by 200 mg increments thereafter. During dose expansion, two new cohorts of patients will be enrolled at the MTD/RP2D to further characterize the safety and pharmacokinetics of ARN-810.
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.
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Aditya Bardia, MD 617-643-2208 email@example.com|
|Principal Investigator: Aditya Bardia, MD|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Maura Dickler, MD 646-888-5456 firstname.lastname@example.org|
|Principal Investigator: Maura Dickler, MD|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Shireen Williams 615-875-6278 email@example.com|
|Principal Investigator: Ingrid A Mayer, MD|
|Study Director:||Edna Chow Maneval, PhD||Seragon Pharmaceuticals|