Dose-escalation, Safety and Pharmacokinetic Study of Briciclib in Advanced Solid Tumors

Summary

The main objectives of this study are to determine the safety profile of briciclib, an experimental anti-cancer drug, as it is administered intravenously once weekly as escalating doses in adult patients with advanced cancer and solid tumors, and to determine the highest dose of briciclib that can be safely given. Secondary objectives are to determine how the amount of briciclib in circulation changes over time and how much briciclib gets into the urine for excretion, and to document potential anti-tumor effects of briciclib.

Timeline

Start

2014-06

Primary completion

2015-12

Completion

2015-12

Outcome

Outcome not reported

Stopped: “The study was placed on hold by the FDA due to manufacturing issues and was not restarted.”

Drugs

Indications