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Clinical Trial Finder

Search Results

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

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & 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.
  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04640025
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Incyte Corporation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Lance Leopold, MD
Principal Investigator Affiliation Incyte Corporation
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Austria, Belgium, Canada, Germany, Greece, Israel, Italy, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Myelofibrosis, Postlung Transplant (Bronchiolitis Obliterans), Chronic Graft Versus Host Disease
Arms & Interventions

Arms

Experimental: itacitinib

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.

Interventions

Drug: - itacitinib

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope National Medical Center, Duarte, California

Status

Not yet recruiting

Address

City of Hope National Medical Center

Duarte, California, 31010

Site Contact

medinfo@incyte.com

1.855.463.3463

Aurora, Colorado

Status

Completed

Address

Anschutz Cancer Pavilion - University of Colorado

Aurora, Colorado, 80045

Site Contact

medinfo@incyte.com

1.855.463.3463

Parkview Research Center, Fort Wayne, Indiana

Status

Recruiting

Address

Parkview Research Center

Fort Wayne, Indiana, 46845

Site Contact

medinfo@incyte.com

1.855.463.3463

Cleveland Clinic, Cleveland, Ohio

Status

Not yet recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Site Contact

medinfo@incyte.com

1.855.463.3463

University of Pennsylvania Hospital, Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104

Site Contact

medinfo@incyte.com

1.855.463.3463

Temple University, Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

Temple University

Philadelphia, Pennsylvania, 19140

Site Contact

medinfo@incyte.com

1.855.463.3463

Nashville, Tennessee

Status

Recruiting

Address

Tennessee Oncology Blood & Marrow Transplant

Nashville, Tennessee, 37203

Site Contact

medinfo@incyte.com

1.855.463.3463

Texas Oncology San Antonio, San Antonio, Texas

Status

Not yet recruiting

Address

Texas Oncology San Antonio

San Antonio, Texas, 78240

Site Contact

medinfo@incyte.com

1.855.463.3463

International Sites

Ordensklinikum Linz Gmbh Elisabethinen, Linz, Austria

Status

Not yet recruiting

Address

Ordensklinikum Linz Gmbh Elisabethinen

Linz, , 04020

Site Contact

medinfo@incyte.com

1.855.463.3463

Leuven, Belgium

Status

Not yet recruiting

Address

Universitaire Ziekenhuis Leuven - Gasthuisberg

Leuven, , 03000

Site Contact

medinfo@incyte.com

1.855.463.3463

St Paul'S Hospital, Vancouver, Canada

Status

Recruiting

Address

St Paul'S Hospital

Vancouver, , V6Z2A5

Site Contact

medinfo@incyte.com

1.855.463.3463

Universitatsklinikum Halle (Saale), Halle, Germany

Status

Not yet recruiting

Address

Universitatsklinikum Halle (Saale)

Halle, , 06120

Site Contact

medinfo@incyte.com

1.855.463.3463

Hamburg, Germany

Status

Not yet recruiting

Address

University Medical Centre Hamburg-Eppendorf Centre of Oncology

Hamburg, , 20251

Site Contact

medinfo@incyte.com

1.855.463.3463

University Hospital Mannheim, Mannheim, Germany

Status

Not yet recruiting

Address

University Hospital Mannheim

Mannheim, , 68167

Site Contact

medinfo@incyte.com

1.855.463.3463

Chaidari, Greece

Status

Not yet recruiting

Address

University Hospital of West Attica - Attikon

Chaidari, , 12462

Site Contact

medinfo@incyte.com

1.855.463.3463

Jerusalem, Israel

Status

Not yet recruiting

Address

Hadassah Hebrew University Medical Center Ein Karem Hadassah

Jerusalem, , 91120

Site Contact

medinfo@incyte.com

1.855.463.3463

Azienda Policlinico Vittorio Emanuele, Catania, Italy

Status

Not yet recruiting

Address

Azienda Policlinico Vittorio Emanuele

Catania, , 95123

Site Contact

medinfo@incyte.com

1.855.463.3463

Reggio Di Calabria, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti

Reggio Di Calabria, , 89100

Site Contact

medinfo@incyte.com

1.855.463.3463

Aou San Giovanni Di Dio E Ruggi, Salerno, Italy

Status

Not yet recruiting

Address

Aou San Giovanni Di Dio E Ruggi

Salerno, , 84131

Site Contact

medinfo@incyte.com

1.855.463.3463

Granada, Spain

Status

Not yet recruiting

Address

Hospital Universitario Virgen de Las Nieves

Granada, , 18012

Site Contact

medinfo@incyte.com

1.855.463.3463

Hospital Universitario Ramon Y Cajal, Madrid, Spain

Status

Not yet recruiting

Address

Hospital Universitario Ramon Y Cajal

Madrid, , 28034

Site Contact

medinfo@incyte.com

1.855.463.3463

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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