A Phase 1 Study of Ruxolitinib plus Abemaciclib to Treat Myelofibrosis

Full Title

A Phase I Study of Ruxolitinib Plus Abemaciclib for Patients with Primary or Post-polycythemia Vera/Essential Thrombocythemia Myelofibrosis

Purpose

In this study, researchers want to find the highest dose of the drug abemaciclib that can be given safely with ruxolitinib in people with myelofibrosis that has developed on its own (primary myelofibrosis) or as a complication of the blood diseases polycythemia vera or essential thrombocythemia. In people with myelofibrosis, the bone marrow is not able to make enough blood cells. The spleen is bigger than normal, making the stomach feel very full. Patients may also have fever and night sweats.

Doctors think that giving ruxolitinib, a standard medication for myelofibrosis, in combination with abemaciclib (a breast cancer medication that is investigational in this study) may be a useful treatment. Both ruxolitinib and abemaciclib block specific proteins that play a role in cancer growth. By blocking these proteins, the drugs may cause myelofibrosis to stop growing.

Participants in this study will receive one of three doses of abemaciclib in combination with ruxolitinib. Both medications are taken orally (by mouth).

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Raajit Rampal at 646-608-3746.

Protocol
22-075
Phase
Phase I (phase 1)
Disease Status
Newly Diagnosed & Relapsed/Refractory
Investigator
Co-Investigators
ClinicalTrials.gov ID
NCT05714072