Clinical trial NCT04640025: A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib
Official title: A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (INCB039110)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Myelofibrosis
Postlung Transplant (Bronchiolitis Obliterans)
Chronic Graft Versus Host Disease
Keywords: itacitinib
INCB39110
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2020-11-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Individual patients will continue to be treated with itacitinib in accordance with the parent study under which they were enrolled.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment Emergent Adverse Events (TEAE's)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Aurora
country: United States
facility: Anschutz Cancer Pavilion-University of Colorado
state: Colorado
city: Fort Wayne
country: United States
facility: Parkview Cancer Institute
state: Indiana
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Department of Thoracic Medicine and Surgery
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: San Antonio
country: United States
facility: Texas Oncology San Antonio
state: Texas
city: Linz
country: Austria
facility: Ordensklinikum Linz Gmbh Elisabethinen
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuis Leuven - Gasthuisberg
city: Vancouver
country: Canada
facility: Providence Health
state: British Columbia
city: Halle
country: Germany
facility: Universitatsklinikum Halle (Saale)
city: Hamburg
country: Germany
facility: University Medical Centre Hamburg-Eppendorf Centre of Oncology
city: Mannheim
country: Germany
facility: University Hospital Mannheim
city: Chaidari
country: Greece
facility: University Hospital of West Attica - Attikon
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah
city: Catania
country: Italy
facility: Azienda Policlinico Vittorio Emanuele
city: Reggio Di Calabria
country: Italy
facility: Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti
city: Salerno
country: Italy
facility: Aou San Giovanni Di Dio E Ruggi
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
Study officials:
affiliation: Incyte Corporation
name: Lance Leopold, MD
role: STUDY_DIRECTOR
References: