(08-02) A Phase 1, Dose-Escalation Study of the Safety, Pharmacokinetics and Efficacy of Weekly Intravenous Briciclib in Patients with Advanced Solid Tumors
Description: 

Primary objective: The primary objective of the study is to determine the safety profile, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and recommended Phase II dose (RPTD) of IV briciclib administered once weekly as escalating doses in adult patients with advanced cancer and solid tumors. Secondary objectives: Secondary objectives are as follows: To determine the plasma and urinary PK profile of IV briciclib administered once weekly as escalating doses to patients with advanced cancer and solid tumors; and to document potential anti-tumor effects of IV briciclib in these patients.The exploratory objective of this study is to evaluate the biological effect of IV briciclib on cell-cycle pathways, cyclin D1, and other potential surrogate biomarker(s) of efficacy

Study Number: 

PH 248913

Phase: 
I
Principal Investigator: 
ClinicalTrials.Gov ID: 
NCT02168725

To inquire about participating in these studies, call 1-877-ASK-RPCI (1-877-275-7724) or e-mail askrpci@roswellpark.org.