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NCT06073847 Clinical Trial

A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis

Primary Myelofibrosis Clinical Trial

Official title:
Inrebic® (Fedratinib) Post-Marketing Surveillance in Korean Patients With Myelofibrosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06073847
Other study ID # CA054-005
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 13, 2023
Est. completion date December 20, 2027

Study information
Verified date April 2024
Source Bristol-Myers Squibb
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess the real-world safety of fedratinib for the treatment of adult participants with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post-PV MF), or post essential thrombocythemia myelofibrosis (post-ET MF) who were previously treated with ruxolitinib. Participants will represent the overall patient population with PMF, post-PV MF or post-ET MF who lost adequate response to and/or are intolerant to ruxolitinib. Inadequate response definitions will follow Ministry of Food and Drug Safety-approved label and reimbursement criteria of the Health Insurance Review & Assessment Service.

Recruitment information / eligibility
Status Recruiting
Enrollment 137
Est. completion date December 20, 2027
Est. primary completion date December 20, 2027
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Participants 19 years of age or older - Participants who will receive fedratinib according to the approved label - For the first 2 years after marketing authorization, all participants who have received or are receiving fedratinib will also be registered - Participants who signed the informed consent form Exclusion Criteria: - Participants who have been prescribed fedratinib for an indication not approved in Korea - Participants who have been prescribed fedratinib at a dose not approved in Korea - Participants for whom fedratinib is contraindicated as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fedratinib
According to the approved label

Locations
Country Name City State
Korea, Republic of Bristol-Myers Squibb YH Seoul
Korea, Republic of PPC Korea Co.,Ltd Seoul

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to Inrebic® (fedratinib) Up to 6 months
See also
  Status Clinical Trial Phase
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Not yet recruiting NCT06327100 - Open Label Phase 2 Study of Tasquinimod in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF) Phase 2
Active, not recruiting NCT00095784 - Decitabine in Treating Patients With Myelofibrosis Phase 2
Recruiting NCT02897297 - Myeloproliferative Neoplastic Diseases Observatory From Brest
Terminated NCT02091752 - A Phase II Study of Re-treatment of Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event (ReTreatment Trial) Phase 2
Completed NCT01445769 - Alternative Dosing Strategy of Ruxolitinib in Patients With Myelofibrosis Phase 2
Completed NCT01233921 - Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer N/A
Unknown status NCT01298934 - LBH589 (Panobinostat) for the Treatment of Myelofibrosis Phase 1/Phase 2
Terminated NCT00387426 - Sunitinib in Treating Patients With Idiopathic Myelofibrosis Phase 2
Completed NCT05044026 - A Prospective, Two-arm, Non-interventional Study of JAKAVI® (Ruxolitinib) in Patients With Myelofibrosis
Active, not recruiting NCT03952039 - An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib Phase 3
Active, not recruiting NCT02530619 - Alisertib in Treating Patients With Myelofibrosis or Relapsed or Refractory Acute Megakaryoblastic Leukemia N/A
Completed NCT01588015 - Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant Phase 1
Completed NCT01731951 - Imetelstat Sodium in Treating Participants With Primary or Secondary Myelofibrosis Phase 2
Completed NCT01371617 - A Phase 2 Study With IPI-926 in Patients With Myelofibrosis Phase 2
Active, not recruiting NCT02251821 - JAK Inhibitor Before Donor Stem Cell Transplant in Treating Patients With Primary or Secondary Myelofibrosis Phase 2
Active, not recruiting NCT04446650 - A Study of Fedratinib in Japanese Subjects With DIPSS (Dynamic International Prognostic Scoring System)- Intermediate or High-risk Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (Post-ET MF) Phase 1/Phase 2
Completed NCT01981850 - A Phase 2 Study of RO7490677 In Participants With Myelofibrosis Phase 2
Withdrawn NCT04283526 - Study of Select Combinations in Adults With Myelofibrosis Phase 1
Withdrawn NCT02584777 - A Phase II Non-Controlled, Open-Label, Efficacy, Safety, Pharmacokinetic, and Pharmacodynamic Study of Pacritinib in Myelofibrosis Phase 2

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