A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib

Myelofibrosis Clinical Trial

Official title:

A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (INCB039110)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04640025
• Other study ID #: INCB 39110-801
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 10, 2021
• Est. completion date: June 22, 2026

Study information

• Verified date: April 2024
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a mutli-center open-label study to provide continued supply of itacitinib to participants from the following Incyte-sponsored studies of itacitinib: INCB39110-209, INCB39110-213, INCB39110-214, INCB39110-230, and 39110-309. Eligible participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. The original study is referred to as the "parent protocol".

Participants who receive itacitinib in this study may continue treatment as long as the regimen is tolerated, the participant is deriving clinical benefit (in the opinion of the investigator), and the participant does not meet discontinuation criteria.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: June 22, 2026
• Est. primary completion date: June 22, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Currently enrolled and receiving treatment in an Incyte-sponsored itacitinib (INCB39110)-based clinical study (parent Protocol).

• Currently tolerating treatment as defined by the parent Protocol.

• Currently receiving clinical benefit from itacitinib-based treatment, as determined by the investigator.

• Has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.

• Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this Protocol.

• Willingness to avoid pregnancy or fathering children..

• Ability to comprehend and willingness to sign an ICF.

Exclusion Criteria:

• Able to access itacitinib therapy commercially.

• Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.

• Pregnant or breastfeeding women.

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Obliterans
• Bronchiolitis Obliterans Syndrome
• Chronic Graft Versus Host Disease
• Graft vs Host Disease
• Myelofibrosis

Intervention

Drug:
• itacitinib
Participants will self-administer itacitinib orally using intact tablets with water and without regard to food.

Locations

Country	Name	City	State
Austria	Ordensklinikum Linz Gmbh Elisabethinen	Linz
Belgium	Universitaire Ziekenhuis Leuven - Gasthuisberg	Leuven
Canada	Providence Health	Vancouver	British Columbia
Germany	Universitatsklinikum Halle (Saale)	Halle
Germany	University Medical Centre Hamburg-Eppendorf Centre of Oncology	Hamburg
Germany	University Hospital Mannheim	Mannheim
Greece	University Hospital of West Attica - Attikon	Chaidari
Israel	Hadassah Hebrew University Medical Center Ein Karem Hadassah	Jerusalem
Italy	Azienda Policlinico Vittorio Emanuele	Catania
Italy	Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti	Reggio Di Calabria
Italy	Aou San Giovanni Di Dio E Ruggi	Salerno
Spain	Hospital Universitario Virgen de Las Nieves	Granada
Spain	Hospital Universitario Ramon Y Cajal	Madrid
United States	Anschutz Cancer Pavilion-University of Colorado	Aurora	Colorado
United States	Cleveland Clinic	Cleveland	Ohio
United States	City of Hope National Medical Center	Duarte	California
United States	Parkview Cancer Institute	Fort Wayne	Indiana
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Temple University Department of Thoracic Medicine and Surgery	Philadelphia	Pennsylvania
United States	Texas Oncology San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Germany,  Greece,  Israel,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Emergent Adverse Events (TEAE's)	Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.	3 years