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

K0706 is being developed for patients with heavily pre-treated chronic myeloid leukemia who have limited or no treatment options. It is hoped that the drug will provide patients with advanced disease an opportunity of clinical benefit and improved life expectancy.

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
geetanjali.chimote@sparcmail.com

Principal investigator

Mudgal Kothekar, MD, SPARC
mudgal.kothekar@sparcmail.com

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 2

Leuven
SPARC Site 1

France

Marseille Cedex 9
SPARC Site 4

Pierre-Bénite
SPARC Site 7

Tours Cedex 9
SPARC Site 5

India

Kolkata
SPARC Site 11

Kolkata, West Bengal, 700026
Jaipur
SPARC Site 27

Madurai
SPARC Site 14

Mumbai
SPARC Site 10

Mumbai
SPARC Site 15

Nashik, Maharashtra 422004
SPARC Site 28

Pune, Maharashtra 411004
SPARC Site 26

Italy

Meldola
SPARC Site 16

Milano
SPARC Site 17

Monza, Milano 20900
SPARC Site 29


Korea, Republic of

Seoul, 06591
SPARC Site 25

United Kingdom

London, Greater London, W120HS
SPARC Site 30

London
SPARC Site 18

United States

California
Glendale, 91204
SPARC Site 19

New York
New York, 10065
SPARC Site 31

Valhalla, 10595
SPARC Site 23

Texas
Dallas, 75246
SPARC Site 24

Houston, 77030
SPARC Site 21

Utah
Salt Lake City, 84132
SPARC Site 33

Seattle, 98109
SPARC Site 32

 


 
   
 

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