Hi Pete! You know I can't resist answering a qu
Post# of 72440
Hi Pete!
You know I can't resist answering a question like this! (candy to a baby). Thanks!
So - ctix study has 2 main components, establishing MTD and defining pharmacokinetics.(pharmacokinetics [fahr?mah-ko-k?-net´iks] the study of the movement of drugs in the body, including the processes of absorption, distribution, localization in tissues, biotransformation, and excretion) If this was MTD only study, they could end early. Indeed, in their defined goals, they state "up to 6 months" and "up to 4 weeks" for parts of MTD establishment. So - that part of the study may not take 6 months. (they have to establish MTD so if unexpected awesome results occur early they still have to keep going until this parameter defined). But they then listed completely specific time parameters in their pharmacokinetic section. They plan to measure tumor size and serum tumor markers every month thru and including month 6. So if MTD is found prior to last cohort, the tumor evaluations will continue until the 6 month mark, precluding early end to the trial - but giving much more quality information. If tumors don't shrink but serum tumor markers measurably reduce, the trial can still be called successful.