Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06327100
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-03-15
Brief Title:
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
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn if tasquinimod either alone or in combination with ruxolitinib can help to control PMF post-PV MF or post-ET MF
Detailed Description:
Primary Objectives To determine anti-tumor activity of tasquinimod in patients with PMF post-PV MF and post-ET MF in a monotherapy and in combination with stable dose of ruxolitinib based on the measurement of the objective response rate ORR which is defined as the proportion of patients with CR complete remission PR partial remission or CI clinical improvement after six cycles of treatment according to the International Working Group IWG consensus criteria
Secondary Objectives To determine safety of tasquinimod in patients with PMF post-PV MF and post-ET MF in a monotherapy and in combination with stable dose of ruxolitinib
To determine time to response and response duration
To assess changes in symptom burden as assessed by Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score MFSAF v40
To assess changes in bone marrow fibrosis grade
To assess the pharmacokinetics PK of tasquinimod in blood to determine whether the systemic exposure of tasquinimod when administered alone or in combination with ruxolitinib in patients with MF
To assess correlation of response resistance to tasquinimod with baseline genetic markers cytogenetic alterations and mutations determined by NextGen sequencing of an 81-gene myeloid panel
Secondary Objectives To determine safety of tasquinimod in patients with PMF post-PV MF and post-ET MF in a monotherapy and in combination with stable dose of ruxolitinib
To determine time to response and response duration
To assess changes in symptom burden as assessed by Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score MFSAF v40
To assess changes in bone marrow fibrosis grade
To assess the pharmacokinetics PK of tasquinimod in blood to determine whether the systemic exposure of tasquinimod when administered alone or in combination with ruxolitinib in patients with MF
To assess correlation of response resistance to tasquinimod with baseline genetic markers cytogenetic alterations and mutations determined by NextGen sequencing of an 81-gene myeloid panel
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| NCI-2024-02551 | OTHER | NCI-CTRP Clinical Registry | None |