Spots Global Cancer Trial Database for To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213)
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Trial Identification
Brief Title: To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213)
Official Title: A 2-Part, Phase 2, Open-Label Study of the Safety, Tolerability, and Efficacy of Itacitinib Immediate Release in Participants With Primary Myelofibrosis or Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis) Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy
Study ID: NCT04629508
Interventions
Study Description
Brief Summary: This is a 2-part study. In Part 1, participants will be dosed at 2 different dose levels in order to select the RP2D for Part 2 of the study.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Tulane University, New Orleans, Louisiana, United States
Rcca Md, Llc, Bethesda, Maryland, United States
Midamerica Cancer Care, Kansas City, Missouri, United States
New Jersey Hematology Oncology Associates Llc, Brick, New Jersey, United States
Baptist Cancer Center, Memphis, Tennessee, United States
Vanderbilt University, Nashville, Tennessee, United States
Texas Oncology - Baylor Sammons Cancer Center, Dallas, Texas, United States
Renovatio Clinical Consultants Llc, Spring, Texas, United States
Interne 1 - Hematologie Mit Stammzelltransplantation, Hemostaseologie Und Medizinische Onkologie Ord, Linz, , Austria
Cliniques Universitaires Ucl Saint-Luc, Brussels, , Belgium
Jessa Ziekenhuis, Hasselt, , Belgium
AZ DELTA, Roeselare, , Belgium
Chu Ucl Namur University Hospital Mont-Godinne, Yvoir, , Belgium
Universitaetsmedizin Greifswald, Greifswald, , Germany
Universitatsklinikum Halle (Saale), Halle (saale), , Germany
Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele, Milan, , Italy
Aou San Giovanni Di Dio E Ruggi, Salerno, , Italy
Treviso Hospital, Treviso, , Italy
Pratia Hematologia Katowice, Katowice, , Poland
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitari I Politecnic La Fe, Valencia, , Spain
Contact Details
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