A Phase II Trial Of The JAK-Inhibitor Ruxolitinib (INCB018424) In Combination With Exemestane For Patients With Estrogen Receptor (ER) Positive Advanced Breast Cancer)
Abstract Brief abstract (250 words or less) describing the study in language understandable
to a lay person. Include brief description of the purpose, target disease/condition if
applicable, key eligibility criteria, and main study interventions This is a Phase II
investigator-Initiated trial of the Investigational Drug, Ruxolitinib, in combination with
Exemestane in patients with estrogen-receptor positive advanced breast cancer. The objective
of this study is to determine the preliminary safety and efficacy of the combination of
exemestane and Ruxolitinib (INCB018424). A maximum of 25 people will be enrolled on this
study at the University of Pennsylvania.
As part of this study, subjects have the option of providing separate consent for research
related biopsies (at baseline and Cycle 1/Day 22). If they provide consent, subjects will be
co-enrolled on a separate sample acquisition research study under the direction of Dr.
Angela DeMichele (IRB #811841/UPCC#17110: Collection of Tumor Tissue, Blood and Clinical
Data from Patients with Advanced Breast Cancer (short name TRACR-MET)) through which these
biopsies will be performed with Radiology support. The study team will review this separate
consent with the study subjects considering participation in this optional component so that
they can make a fully educated decision regarding whether or not they would like to
participate.
Interventional
Primary Purpose: Treatment
Number of Adverse Events
Yes
Angela DiMichele, MD
Principal Investigator
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
UPCC 02112
NCT01594216
April 2012
April 2015
Name | Location |
---|---|
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |