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CLR_15_03 = Safety, Tolerability and Pharmacokinetics of K0706 [Asia, Europe, USA]

Study title

Safety, Tolerability and Pharmacokinetic Study of K0706

Scientific 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) (EudraCT 2016-001754-18, ClinicalTrials.gov NCT02629692)

Indication and most important inclusion criteria

This study includes male or female patients who:

- are willing and able to give written, and dated, informed consent
- are at least 18 years old
- are willing and able to comply with the scheduled visits
- have been diagnosed with Philadelphia chromosome positive (Ph+) in chronic phase (CML-CP), advanced phase (CML-AP) or blast phase (CML BP), or Ph+ Acute lymphoblastic leukemia (ALL)
-- have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2
- have adequate organ and immune system function

Short description of intervention

This is an open-label dose-escalation study to determine the safety, tolerability, pharmacokinetics and activity of the novel tyrosine kinase inhibitor K0706.

Part A of the study in healthy volunteers has been completed. Part B of the study in patients is ongoing.

Type of study

7. Other trials

Current status

Recruiting

Part A of the study in healthy volunteers has been completed.
Part B of the study in patients is ongoing.

Study sponsor

Sun Pharma Advanced Research Company (SPARC) Limited, India

Scientific lead / contact

Geetanjali Chimote, MBBS,PhD, SPARC

Principal investigator

Mudgal Kothekar, MD, SPARC

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)

Study centers / principal investigators

Belgium
Antwerpen
SPARC Site 1

Leuven
SPARC Site 1


France

Pierre-Bénite
SPARC Site 7


India

Madurai
SPARC Site 14

Mumbai
SPARC Site 15


Korea, Republic of

SPARC Site 25
Seoul, 06591


United States

Texas
SPARC Site 21
Houston, 77030

The study is also planned to be performed in the Czech Republic, Italy, Poland and the United Kingdom.

 


 
   
 

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