Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-16 @ 10:43 AM
Study NCT ID:
NCT02629692
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-31
First Post:
2015-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment of Ph+ CML Resistant/Intolerant to ≥3 Prior CML Therapies
Sponsor:
Sun Pharma Advanced Research Company Limited
Organization:
Study Overview
Official Title:
A Two-Part Phase 1/2 Study to Determine Safety, Tolerability, Pharmacokinetics, and Activity of K0706, a Novel Tyrosine Kinase Inhibitor (TKI), in Healthy Subjects and in Subjects With Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML
Detailed Description:
Part A ( for Healthy volunteers) of the study is completed.
Part B dose-escalation study is completed. Recruitment in dose expansion is completed.
Part C study in subjects with treatment-resistant/intolerant is ongoing for the enrolled subjects.
Part B dose-escalation study is completed. Recruitment in dose expansion is completed.
Part C study in subjects with treatment-resistant/intolerant is ongoing for the enrolled subjects.
Study Oversight
Has Oversight DMC:
False
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?: