Setting the record straight

A phase I clinical trial of Gleevec plus PKC412 has started at Charite Campus Buch in Berlin. The January newsletter incorrectly reported that it was a phase II trial, and that Oregon Health & Sciences University in Portland also was starting this trial, when in fact it is a phase I trial.

Adds Life Raft Science Coordinator Jerry Call: “Apparently, the phase I trial in Berlin is demonstrating a significant interaction between PKC412 and Gleevec. Our understanding is that PKC412 is causing the Gleevec to leave the body too quickly. This will require a higher than anticipated dose of Gleevec to achieve normal levels of Gleevec in the body.

“The Gleevec plus PKC412, and Gleevec plus RAD001 (RAD) phase I trials emphasize the importance of phase I trials for drug combinations. Both trials are demonstrating significant drug interactions. In the Gleevec+RAD trial, the Gleevec is causing an increase in the amount of RAD in the body, while in the Gleevec+PKC412 trial, the PKC412 is causing a decrease in the amount of Gleevec in the body.”