NCT05524857

Combination of Fedratinib and Decitabine for Myeloproliferative Neoplasms (MPN)- Accelerated Phase (AP)/Blast Phase (BP)

Phase I Trial of Fedratinib in Combination With Decitabine in Patients With Myeloproliferative Neoplasms in Accelerated and Blast Phase

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Joseph Jurcic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to study the safety and tolerability and to establish the maximum tolerated dose (MTD) of the combination of two drugs, fedratinib and decitabine, for the treatment of advanced-phase MPNs.

Detailed description

This is a single center phase I dose-escalation trial of Fedratinib in Combination with Decitabine in Patients with Myeloproliferative Neoplasms. The primary objective is to determine the maximum tolerated dose of the combination therapy, using a 3+3 dose escalation algorithm. Fedratinib will be administered at 2 dose levels: 300 mg and 400 mg by mouth, once daily. Fedratinib will be administered concomitantly with decitabine 20 mg/m2 intravenously over 1 hour per day for 5 days in 28-day cycles.

Conditions

• Myeloproliferative Neoplasm

Interventions

Type	Name	Description
DRUG	Fedratinib Oral Capsule 300 mg	300 mg by mouth, once daily
DRUG	Decitabine 20 mg/m2	20 mg/m2 for injection, for intravenous use
DRUG	Fedratinib Oral Capsule 400 mg	400 mg by mouth, once daily

Timeline

• Start date: 2022-01-28
• Primary completion: 2024-04-09
• Completion: 2024-04-09
• First posted: 2022-09-01
• Last updated: 2024-04-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study