Panobinostat and Ruxolitinib in Primary Myelofibrosis, Post-polycythemia Vera-myelofibrosis or Post-essential Thrombocythemia-myelofibrosis

• Status: Completed
• Trial end date: 2020-06-22
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess safety as well as establish a Recommended Phase II dose of the combination of panobinostat and ruxolitinib in patients with or without the JAK2V617F mutation who have been diagnosed with primary myelofibrosis (PMF), Post Essential Thrombocythemia Myelofibrosis (PET MF), or Post-Polycythemia Vera Myelofibrosis (PPV MF).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Panobinostat

Criteria

Inclusion Criteria:

• Diagnosis of myelofibrosis, either PMF, PPV or PET MF

• Palpable splenomegaly ≥ 5cm

• May have been previously treated with either panobinostat or ruxolitinib (unless discontinued for clinically relevant toxicities)

• Acceptable lab ranges for all organ systems

• Specifically: Platelet count > 100,000 not reached with the aide of transfusions

• Blast count < 10% at screening

• ECOG ≤ 2

• Must be able to discontinue all drugs being used to treat MF at least 7 days prior to starting study drug

Exclusion Criteria:

• Active malignancy

• Clinically significant heart disease

• Splenic irradiation within 12 months of starting study drug

• Need for ongoing systemic anticoagulation with the exception of Aspirin < 150mg/day or Low Molecular Weight Heparin

• History of platelet dysfunction or bleeding disorder in the 6 months prior to screening

• Patient is at risk for spontaneous bleeding

• Willing and/or eligible for stem-cell transplantation

• Impairment of gastro-intestinal function that may impact the absorption of study treatment

• Unwilling to use highly effective methods of contraception during dosing and for 13 weeks (female participants) or for 6 months (male participants and their female partners) after stopping study treatment