BBI: TP-3654 in Patients with Myelofibrosis

What is the 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.

What is the Condition Being Studied?

Myelofibrosis

Who Can Participate in the Study?

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.

Age Group
Adults

What is Involved?

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
Principal Investigator
Associate Professor of Medicine
Protocol Number
IRB: PRO00103829
NCT: NCT04176198
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL