Ignite Creation Date:
2024-05-06 @ 2:50 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04446650
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-08
First Post:
2020-06-16
Brief Title:
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
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
A Phase 12 Multicenter Single-arm Open-label Study to Evaluate the Efficacy and Safety 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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will be conducted in compliance with the International Council for Harmonisation ICH of Technical Requirements for Registration of Pharmaceuticals for Human UseGood Clinical Practice GCP and applicable regulatory requirements
This is a Phase 12 multicenter single arm open-label study in Japanese subjects with DIPSS intermediate or high-risk PMF post-PV or post-ET MF The study consists of 2 parts Phase 1 part to determine safety and tolerability and a RP2D The Phase 1 portion of the study will explore one or more drug doses for fedratinib 300 mg and 400 mg using a mTPI-2 design Following completion of dose escalation and determination of MTD andor a RP2D the study will progress into the Phase 2 part to further evaluate the efficacy and safety
The study will consist of 3 periods a Screening Period a Treatment Period including a 30-day follow-up after last dose visit and a survival follow-up period
This is a Phase 12 multicenter single arm open-label study in Japanese subjects with DIPSS intermediate or high-risk PMF post-PV or post-ET MF The study consists of 2 parts Phase 1 part to determine safety and tolerability and a RP2D The Phase 1 portion of the study will explore one or more drug doses for fedratinib 300 mg and 400 mg using a mTPI-2 design Following completion of dose escalation and determination of MTD andor a RP2D the study will progress into the Phase 2 part to further evaluate the efficacy and safety
The study will consist of 3 periods a Screening Period a Treatment Period including a 30-day follow-up after last dose visit and a survival follow-up period
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1252-2577 | REGISTRY | WHO | None |