NCT02629692

Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment of Ph+ CML Resistant/Intolerant to ≥3 Prior CML Therapies

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: Sun Pharma Advanced Research Company Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Healthy (For Part A)
• Chronic Myeloid Leukemia (for Part B and C)

Interventions

Type	Name	Description
DRUG	Vodobatinib (K0706) capsules	Part A: Vodobatinib (K0706) capsules in single ascending doses. Part B: Oral Vodobatinib (K0706) capsules in multiple ascending doses, once daily. Part C: Oral Vodobatinib (K0706) capsules at recommended phase 2 dose of 174 mg, once daily.

Timeline

• Start date: 2016-06-27
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2015-12-14
• Last updated: 2024-07-31

Locations

38 sites across 11 countries: United States, Belgium, France, Hungary, India, Italy, Romania, South Korea, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study