Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509899
Status:
COMPLETED
Last Update Posted:
2018-03-12
First Post:
2007-07-30
Brief Title:
Open Label Ruxolitinib INCB018424 in Patients With Myelofibrosis and Post Polycythemia VeraEssential Thrombocythemia Myelofibrosis
Sponsor:
Incyte Corporation
Organization:
Incyte Corporation
Study Overview
Official Title:
A Phase 12 Open-Label Study of the JAK2 Inhibitor INCB018424 Administered Orally to Patients With Primary Myelofibrosis PMF and Post Polycythemia VeraEssential Thrombocythemia Myelofibrosis Post-PVET
Status:
COMPLETED
Status Verified Date:
2018-02
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:
To determine the safety tolerability and effectiveness of ruxolitinib INCB018424 administered orally to patients with Primary Myelofibrosis PMF Post Polycythemia Vera Myelofibrosis PPV-MF and Essential Thrombocythemia Myelofibrosis PET-MF
Detailed Description:
This is a multicenter open-label non-randomized dose escalation study of ruxolitinib a small molecule Janus kinase JAK inhibitor administered orally to patients with PMF PPEV-MF or PET-MF The study is comprised of 3 parts
Part 1 Dose escalation and determination of maximum tolerated dose complete
Part 2 Exploration of alternative dosing schedules complete
Part 3 Further evaluation of selected dose regimens including additional response measures to explore effect of ruxolitinib on symptoms and other parameters including daily physical activity and long-term survival ongoing
Part 1 Dose escalation and determination of maximum tolerated dose complete
Part 2 Exploration of alternative dosing schedules complete
Part 3 Further evaluation of selected dose regimens including additional response measures to explore effect of ruxolitinib on symptoms and other parameters including daily physical activity and long-term survival ongoing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None