The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
University of Chicago
Chicago, Illinois, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Columbia University Medical Center
New York, New York, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Number of Participants With Dose-Limiting Toxicities
Dose limiting toxicity defined as clinically significant adverse events or laboratory abnormalities occurring during first cycle of study drug administration that are possibly related to study drug and that meet specific criteria defined in the protocol
Time frame: From time of first dose of PLX2853 and combination agent(s) through completion of Cycle 1 (21 days)
Phase 1b (Both Arms): Incidence of TEAEs That Are Related to Treatment
Treatment-emergent adverse events are those reported after study drug has been administered.
Time frame: From time of first dose of PLX2853 and combination agent(s) until 30 days from end of treatment (an average of 103 days)
Determination of Maximum Tolerated Dose
To be evaluated in both PLX2853 + AA + pred and PLX2853 + olap group; If DLTs observed in 2 or more subjects the dose will be considered intolerable and MTD will have been reached.
Time frame: From time of first dose of PLX2853 and combination agent(s) through completion of Cycle 1 (21 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Prednisone (or equivalent) tablets
PLX2853 tablets
PLX2853 tablets
Tennessee Oncology/ Sarah Cannon
Nashville, Tennessee, United States
Virginia Cancer Specialist
Fairfax, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Sarah Cannon Research Institute
London, United Kingdom