NCT02718300

A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis

A Phase 2 Study of the Safety, Tolerability, and Efficacy of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination of parsaclisib and ruxolitinib in subjects with myelofibrosis.

Conditions

• MPN (Myeloproliferative Neoplasms)

Interventions

Type	Name	Description
DRUG	Parsaclisib	Up to 3 oral once a day (QD) doses of parsaclisib. Doses will be taken once daily for 8 weeks, followed by once weekly dosing at the same dose level.
DRUG	Parsaclisib	Two recommended oral QD doses of parsaclisib. Once daily doses of parsaclisib will be taken for 8 weeks, followed by once weekly dosing at the same dose level.
DRUG	Ruxolitinib	The dose of ruxolitinib will be that which the subjects had been taking for at least 8 weeks before the first dose of parsaclisib.
DRUG	Parsaclisib	20 mg oral QD dose of parsaclisib for 8 weeks. After 8 weeks patients will take either 20 mg once weekly or 5 mg once daily.
DRUG	Parsaclisib	2 dose strategies will be compared: 1. 5 mg parsaclisib beginning on Day 1 until end of treatment. 2. 20 mg oral QD dose of parsaclisib for 8 weeks; after 8 weeks patients will take 5 mg once daily.

Timeline

• Start date: 2017-02-08
• Primary completion: 2021-01-28
• Completion: 2022-04-29
• First posted: 2016-03-24
• Last updated: 2024-05-01
• Results posted: 2024-05-01

Locations

39 sites across 1 country: United States

Regulatory

• FDA-regulated drug study