Back to resultsA Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib
Primary Purpose
Myelofibrosis, Postlung Transplant (Bronchiolitis Obliterans), Chronic Graft Versus Host Disease
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
itacitinib
Sponsored by
About this trial
This is an interventional treatment trial for Myelofibrosis focused on measuring itacitinib, INCB39110
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.
Sites / Locations
- City of Hope National Medical Center
- Anschutz Cancer Pavilion-University of Colorado
- Parkview Cancer InstituteRecruiting
- Cleveland ClinicRecruiting
- Hospital of the University of PennsylvaniaRecruiting
- Temple University Department of Thoracic Medicine and SurgeryRecruiting
- Sarah Cannon Research InstituteRecruiting
- Texas Oncology San Antonio
- Ordensklinikum Linz Gmbh ElisabethinenRecruiting
- Universitaire Ziekenhuis Leuven - GasthuisbergRecruiting
- Providence HealthRecruiting
- Universitatsklinikum Halle (Saale)Recruiting
- University Medical Centre Hamburg-Eppendorf Centre of Oncology
- University Hospital MannheimRecruiting
- University Hospital of West Attica - AttikonRecruiting
- Hadassah Hebrew University Medical Center Ein Karem HadassahRecruiting
- Azienda Policlinico Vittorio Emanuele
- Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti
- Aou San Giovanni Di Dio E RuggiRecruiting
- Hospital Universitario Virgen de Las Nieves
- Hospital Universitario Ramon Y CajalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
itacitinib
Arm Description
Participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. Participants who are receiving ruxolitinib under parent protocol INCB39110-209 may continue to receive it as described in that protocol.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04640025
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
June 22, 2026 (Anticipated)
Study Completion Date
June 22, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelofibrosis, Postlung Transplant (Bronchiolitis Obliterans), Chronic Graft Versus Host Disease
Keywords
itacitinib, INCB39110
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Individual patients will continue to be treated with itacitinib in accordance with the parent study under which they were enrolled.
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
itacitinib
Arm Type
Experimental
Arm Description
Participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. Participants who are receiving ruxolitinib under parent protocol INCB39110-209 may continue to receive it as described in that protocol.
Intervention Type
Drug
Intervention Name(s)
itacitinib
Other Intervention Name(s)
INCB039110
Intervention Description
Participants will self-administer itacitinib orally using intact tablets with water and without regard to food.
Primary Outcome Measure Information:
Title
Treatment Emergent Adverse Events (TEAE's)
Description
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (US)
Phone
1.855.463.3463
Email
medinfo@incyte.com
First Name & Middle Initial & Last Name or Official Title & Degree
Incyte Corporation Call Center (ex-US)
Phone
+800 00027423
Email
eumedinfo@incyte.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lance Leopold, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
31010
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Anschutz Cancer Pavilion-University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Completed
Facility Name
Parkview Cancer Institute
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Temple University Department of Thoracic Medicine and Surgery
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Ordensklinikum Linz Gmbh Elisabethinen
City
Linz
ZIP/Postal Code
04020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Universitaire Ziekenhuis Leuven - Gasthuisberg
City
Leuven
ZIP/Postal Code
03000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Providence Health
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2A5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Halle (Saale)
City
Halle
ZIP/Postal Code
D06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Medical Centre Hamburg-Eppendorf Centre of Oncology
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
University Hospital Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital of West Attica - Attikon
City
Chaidari
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Name
Hadassah Hebrew University Medical Center Ein Karem Hadassah
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Name
Azienda Policlinico Vittorio Emanuele
City
Catania
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti
City
Reggio Di Calabria
ZIP/Postal Code
89100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Aou San Giovanni Di Dio E Ruggi
City
Salerno
ZIP/Postal Code
84131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de Las Nieves
City
Granada
ZIP/Postal Code
18012
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD Sharing Time Frame
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD Sharing Access Criteria
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD Sharing URL
https://www.incyte.com/our-company/compliance-and-transparency
Learn more about this trial
A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib
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