Primary Outcome
Open
Treatment Emergent Adverse Events (TEAE's)
Timeframe: 3 years
Myelofibrosis(MF), GVHD
A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of itacitinib
Incyte Study ID:
INCB 39110-801
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Recruitment Complete
Clinical Study Purpose
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.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Mar 2021 - Jun 2026
TYPE
Interventional
PHASE
Phase 2
SEX
Female & Male
AGE
18+ years
ACCEPTS HEALTHY VOLUNTEERS
No
Key Inclusion and Exclusion 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.
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.
Clinical Study Locations
Location
Status
Location
SARAH CANNON RESEARCH INSTITUTE
NASHVILLE, TN, US, 37203
Status
Recruiting
Location
PARKVIEW CANCER INSTITUTE
FORT WAYNE, IN, US, 46845
Status
Recruiting
Location
PROVIDENCE HEALTH
VANCOUVER, BC, Canada, V6Z 2A5
Status
Recruiting
Location
TEXAS ONCOLOGY SAN ANTONIO
SAN ANTONIO, TX, US, 78240
Status
Not yet recruiting
Location
ANSCHUTZ CANCER PAVILION-UNIVERSITY OF COLORADO
AURORA, CO, US, 80045
Status
Completed
Location
CITY OF HOPE NATIONAL MEDICAL CENTER
DUARTE, CA, US, 31010
Status
Not yet recruiting
Protocol Summary
Incyte Study ID:
INCB 39110-801
Primary Purpose:
Treatment
Allocation:
N/A
Study Design:
Single Group Assignment
Masking:
None (Open Label)
Interventions:
Drug
Enrollment:
18
Secondary Outcome
Open