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

Phase 2 Terminated 74 enrolled Incyte Corporation

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2017-02-08
Primary completion: 2021-01-28
Completion: 2022-04-29

Outcome

Missed primary endpoint

Stopped (Enrollment): “A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.”

registry analysis (superiority test); TG5I/M vs TG5D; p = 0.4046; Van Elteren test NCT02718300 ↗

Publications

Yacoub A, Borate U, Rampal RK, Ali H, Wang ES, Gerds AT, Hobbs G, Kremyanskaya M, Winton E, O'Connell C, Goel S, Oh ST, Schiller G, McCloskey J, Palmer J, Holmes H, Hager S, Assad A, Erickson-Viitanen S, Zhou F, Daver N. Phase 2 study of add-on parsaclisib for patients with myelofibrosis and suboptimal response to ruxolitinib: final results. Blood Adv. 2024 Mar 26;8(6):1515-1528. doi: 10.1182/bloodadvances.2023011620.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Parsaclisib	Unknown	5 mg	Oral
Subject	Parsaclisib	Unknown	10 mg	Oral
Subject	Parsaclisib	Unknown	20 mg	Oral
Background	Ruxolitinib	Small molecule	—	—