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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501661-47-00 | Registry Identifier | EU CT Number | |
| 2020-002134-32 | EudraCT Number |
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The decision to close the study was made due to the expiration of remaining drug supply.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| itacitinib | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| itacitinib | Drug | Participants will self-administer itacitinib orally using intact tablets with water and without regard to food. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lance Leopold, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 31010 | United States | ||
| Anschutz Cancer Pavilion-University of Colorado |
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| Label | URL |
|---|---|
| A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib | View source |
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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
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
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.
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Individual patients will continue to be treated with itacitinib in accordance with the parent study under which they were enrolled.
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Open Label
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| Aurora |
| Colorado |
| 80045 |
| United States |
| Parkview Cancer Institute | Fort Wayne | Indiana | 46845 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Temple University Department of Thoracic Medicine and Surgery | Philadelphia | Pennsylvania | 19140 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Texas Oncology San Antonio | San Antonio | Texas | 78240 | United States |
| Ordensklinikum Linz Gmbh Elisabethinen | Linz | 04020 | Austria |
| Universitaire Ziekenhuis Leuven - Gasthuisberg | Leuven | 03000 | Belgium |
| Providence Health | Vancouver | British Columbia | V6Z 2A5 | Canada |
| Universitatsklinikum Halle (Saale) | Halle | D06120 | Germany |
| University Medical Centre Hamburg-Eppendorf Centre of Oncology | Hamburg | 20251 | Germany |
| University Hospital Mannheim | Mannheim | 68167 | Germany |
| University Hospital of West Attica - Attikon | Chaïdári | 12462 | Greece |
| Hadassah Hebrew University Medical Center Ein Karem Hadassah | Jerusalem | 91120 | Israel |
| Azienda Policlinico Vittorio Emanuele | Catania | 95123 | Italy |
| Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti | Reggio Calabria | 89100 | Italy |
| Aou San Giovanni Di Dio E Ruggi | Salerno | 84131 | Italy |
| Hospital Universitario Virgen de Las Nieves | Granada | 18012 | Spain |
| Hospital Universitario Ramon Y Cajal | Madrid | 28034 | Spain |
| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| D001989 | Bronchiolitis Obliterans |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D000092124 | Organizing Pneumonia |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000718170 | itacitinib |
| C000603457 | INCB039110 |
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