Purpose of this Study
We are doing this study to find out if an investigational drug called TP-3654 (the study drug) is a safe and effective treatment for myelofibrosis. The study drug will be tested at different doses to find out what effects, if any, it has on myelofibrosis.
Who Can Participate?
Eligibility
Adults who are diagnosed with intermediate or high-risk primary or secondary myelofibrosis.
For more information about who can join this study, please contact the study team at peggy.alton@duke.edu or 919-684-9220.
What is Involved?
Description
If you choose to join the study, you will receive capsules/tablets of the study drug and take them by mouth once per day or twice per day for 4 weeks at a time (each drug "cycle" lasts for 4 weeks). There are no breaks in between cycles.
Study participation is expected to be about 1 year, but you may continue on the study and receive additional drug cycles if you are responding well and your doctor thinks you might benefit from receiving additional cycles.
Study Details
Full Title
A Phase 1/2, Open-label, Dose-escalation, Safety, Pharmacokinetic,
and Pharmacodynamic Study of Oral TP-3654 in Patients with Intermediate or High-risk Primary or Secondary Myelofibrosis
and Pharmacodynamic Study of Oral TP-3654 in Patients with Intermediate or High-risk Primary or Secondary Myelofibrosis
Principal Investigator
Lindsay
Rein
Protocol Number
PRO00103829
NCT ID
NCT04176198
Phase
I
Enrollment Status
Open to Enrollment