Itacitinib (INCB039110) is a novel and selective JAK1 inhibitor currently in clinical studies for the first-line treatment of patients with acute and chronic GVHD. Vanderbilt Clinical Trials. The clinical trials on this list are studying JAK1 Inhibitor INCB039110. a study on Graft Versus Host Disease. Clinical Trial Outcome Measures Primary Measures. 200mg of oral Itacitinib everyday for 360 days. Data from the ongoing clinical trial program with itacitinib should provide additional evidence about the clinical benefits observed when used earlier in the treatment paradigm. Itacitinib is an experimental drug with an excellent safety record and appears to have activity as ⦠The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). Pre Screen Now NCT04358185. Immunotherapy with alemtuzumab, may induce changes in ⦠Home . If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Clinical Trials Cancer A Phase II, Single-Arm, Open-label Study of Itacitinib, for the prevention of cytokine Release Syndrome (CRS) ⦠200 mg oral for 360 days; Arms, Groups and Cohorts. Patient participation in research studies and clinical trials is critical to understanding IBD and developing new treatments as we work toward a cure. Change in modified ⦠Itacitinib (INCB039110) is a novel and selective JAK1 inhibitor currently in clinical studies for the first-line treatment of patients with acute and chronic GVHD. Furthermore, itacitinib does not affect CAR T-cell antitumor response in in vivo models. The purpose of this study is to assess the safety and efficacy of oral administration of itacitinib once daily for the prevention of cytokine release syndrome (CRS) in male or female participants aged 12 years or older and who are planning to receive tisagenlecleucel or axicabtagene ciloleucel ⦠Clinical Trials; Find a Clinical Trial; Toggle navigation Vanderbilt Clinical Trials. We have numerous clinical trials underway across Oncology and Inflammation & Autoimmunity research areas. Graft Versus Host Disease Studies . All trials Healthy volunteers Pediatric trials. ... Clinical Trials Information. Oral placebo everyday for 360 days. Clinical trials are research studies that involve people. GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease . Incyte-sponsored studies can be found at www.IncyteClinicalTrials.com.. Incyte also supports significant independent research aimed at advancing the study of our products. Itacitinib has been used in trials studying the treatment of Melanoma, Carcinoma, Metastatic Cancer, Endometrial Cancer, and B-cell Malignancies, among others. If interested in learning more about this clinical trial, please contact winshipcto@emory.edu or (404) 778-1868. Itacitinib is a orally administered small molecule Janus kinase 1 (JAK1) inhibitor, being developed by Incyte Corporation for the treatment of cancer, Itacitinib - Incyte Corporation - AdisInsight Either you have JavaScript disabled or your browser does not support Javascript . Patients who participate with this study will be treated with itacitinib instead of steroids. All trials on the list are supported by NCI.. NCIâs basic information about clinical trials explains the types and phases of trials and how they are carried out. Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis Study of the Intestinal Microbiota of Patients With Systemic Sclerosis A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis Autologous Fat Grafting in the ⦠Complementary & Alternative Medicine (CAM) Questions to Ask about Your Treatment. A to Z List of Cancer Drugs. Home . **Clinical trials are research studies that involve people. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form. Itacitinib is a novel, selective, Janus kinase 1 inhibitor in development for treatment of graft-versus-host disease. Patients who participate with this study will be treated with itacitinib instead of steroids. Summary Eligibility Itacitinib was discovered at Incyte , and Incyte holds the global development and commercialization rights for itacitinib with the exception of China , where the rights to develop and commercialize itacitinib ⦠This trial; Search. In the double-blind period, itacitinib administered orally once or twice daily at the protocol-defined dose according to treatment group randomization. This phase Ib trial studies the side effects and best dose of alemtuzumab when given together with itacitinib in treating patients with T-cell prolymphocytic leukemia. It occurs when donor immune cells (the graft) attack normal tissue in the recipientâs body. An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Keywords Lung Cancer non-small cell lung cancer locally advanced metastatic epidermal growth factor receptor (EGFR) inhibition Janus kinase inhibition Lung Neoplasms Carcinoma, Non-Small-Cell Lung Osimertinib Itacitinib Itacitinib + osimertinib Description: This research will assess the effects of Itacitinib as a second line treatment for patients with advanced inflammatory hepatocellular carcinoma (HCC), a type of liver cancer. Graft Versus Host Disease Studies . This study provides the rationale for a phase II clinical trial of itacitinib for the prevention of CRS induced by CAR T-cell therapy (NCT04071366). a study on Graft Versus Host Disease. Interventional study (clinical trial) â studies new tests, treatments, drugs, surgical procedures or devices. People who take part in cancer clinical trials have an opportunity to contribute to scientistsâ knowledge about cancer and to help in the development of improved cancer treatments. 200 mg oral for 360 days; Drug: Placebo. The EU Clinical Trials Register currently displays 39256 clinical trials with a EudraCT protocol, of which 6430 are clinical trials conducted with subjects less than 18 years old. A listing of Myelofibrosis medical research trials actively recruiting patient volunteers. A Study of Itacitinib in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Subjects With Myelofibrosis - NCT03144687. Clinical trials look at new ways to prevent, detect, ⦠About UC Health Clinical Trials. Itacitinib is a novel, selective, Janus kinase 1 inhibitor in development for treatment of graftâversusâhost disease. The purpose of this study is to find out if itacitinib in combination with corticosteroids or other immunosuppressive therapies is safe and effective in people with cGVHD.. Clinical Trials ⦠Clinical Trials. Pemigatinib Clinical Trials (fight) Retifanlimab Clinical Trials (POD1UM) Chronic GVHD. This phase II trial studies how well itacitinib works in treating patients with low risk graft versus host disease. Search for closest city to find more detailed information on a research study in your area. Summary Eligibility for people ages 18 years and up (full criteria) GRAVITAS-309: Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease . The failure of the Phase 3 study, called GRAVITAS-301, erodes the drug's prospects in acute forms of GvHD and ups the risk of the ongoing trials in other patient groups. Itacitinib, which also blocks JAK1, is a large part of that strategy, particularly for expanding into treatment-naive graft-versus-host disease. Title INCB39110-309: A Phase 3 Study of Itacitinib or Placebo in Combination with Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease Itacitinib is an experimental drug with an excellent safety record and appears to have activity as a GVHD treatment. About UCSD Clinical Trials. Why are we doing this research? This study is being done in patients who have been receiving corticosteroids or other immunosuppressive therapies for the treatment of cGVHD for at least 6 months. Clinical Trials / Itacitinib in Advanced Hepatocellular Carcinoma. Clinical trial for Classical Hodgkin Lymphoma , Itacitinib + Everolimus in Hodgkin Lymphoma Clinical Trial INCB 39110-309: A Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids as Initial Treatment for Chronic Graft Versus Host Disease (GRAVITAS-309) This study is to find out if Itacitinib (INCB039110) (the study drug) in combination with corticosteroids is safe and effective in people who ⦠Experimental: Itacitinib. These studies test new ways to prevent, detect, diagnose, or treat diseases. Reducing the incidence and severity of CRS has the potential to benefit clinical practice, including the use of CAR T-cell therapy in patients in previously high-risk populations. Myelofibrosis Clinical Trials. Itacitinib Phase 2 Trial (39110-211) 8p11 MPN. Pemigatinib Clinical Trials (fight) Solid Tumors. Type Small Molecule Groups Investigational Structure Placebo Comparator: Placebo. Clinical Trials / A Study of Itacitinib in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Subjects With ⦠Graft versus host disease is the most common serious complication after bone marrow transplant. About the site . Research. Itacitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This trial; Search. On the basis of these results, a phase II clinical trial of itacitinib for the prevention of CRS induced by CD19-CAR T-cell therapy was initiated ⦠Medical records research â uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best. Home Clinical Trials and Studies Chronic Graft-Versus-Host Disease Treatment Study Clinical Trial Title GRAVITAS-309: A phase 2/3 study of itacitinib and corticosteroids as initial treatment for chronic graft-versus-host disease: Part 2. Group A will evaluate a JAK inhibitor with JAK1 selectivity itacitinib (INCB039110) in combination with pembrolizumab (MK-3475) and Group B will evaluate a PI3K-delta inhibitor (INCB050465) in combination with pembrolizumab to determine the maximum tolerated dose (MTD) or PAD and recommend a dose for the Part 1b ⦠Drug: Itacitinib. Itacitinib Accession Number DB12154 Description. The objective of this study was to assess pharmacokinetics and safety of 300âmg itacitinib dosed in participants with normal renal function (n = 10), severe renal impairment (n = 8), and endâstage renal â¦
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