CLR_15_03 = Safety and anti-leukemic activity of vodobatinib (K0706) for resistant/intolerant CML [Asia, Europe, USA]

What is the purpose of the study

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. The Phase 1 dose escalation study is completed and Phase 2 study has been initiated.

This is an open label, Phase 2 study to determine the efficacy and safety of the novel tyrosine kinase inhibitor vodobatinib (K0706).

What will happen during the study

Part A and B of the study have been completed. In part C, participants will receive vodobatinib (K0706) capsules at the recommended phase 2 dose of 174 mg, once daily.

Key inclusion criteria

This study includes male or female patients who:

• are 18 years or older
• are willing and able to comply with the scheduled visits
• have been diagnosed with Ph+ CML-CP, Ph+ CML-AP, Ph+ CML-BP, who are resistant and/or intolerant to ≥ 3 prior TKIs one of which includes ponatinib
• have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2
• have adequate organ and immune system function.

Further criteria may apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

• have a T315I mutation (Part C)
• have any major surgery, as determined by the Investigator, within 4 weeks of administration of the study drug

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

Where can I find additional information

You can find a study description in the US register ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.

You can also find a study description in the EU Clinical Trials Register. This is a database hosted by the European Medicines Agency (EMA).

Study centers / principal investigators

Belgium

Cliniques Universitaires Saint-Luc
Bruxelles, 1200

France

CHU Angers – Hôpital Hôtel Dieu
Angers, Maine Et Loire, 49033

Hopital Claude Huriez – CHRU Lille
Lille cedex, Nord, 59037

Centre Léon Bérard
Lyon Cedex 08, Rhone, 69373

Institut Paoli Calmettes
Marseille Cedex 9, Bouches-du-Rhône, 13273

CHU de Nantes – Hotel Dieu
Nantes cedex 1, Loire Atlantique, 44000

Hôpital Saint-Louis
Paris cedex 10, Paris, 75475

Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhone, 69495

CHU Poitiers – Hôpital la Milétrie
Poitiers, Vienne, 86021

CHU Rennes – Hopital Pontchaillou
Rennes cedex 9, Ille Et Vilaine, 35033

CHU Amiens – Hopital Sud
Salouel, Somme, 80480

CHU de Nancy – Hôpital de Brabois Adultes
Vandoeuvre-lès-Nancy, Meurthe Et Moselle, 54511

Hungary

Semmelweis Egyetem
Budapest, 1083

Debreceni Egyetem
Debrecen, 4032

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyiregyhaza, 4400

Pecsi Tudomanyegyetem
Pecs, 7624

India

Tata Medical Centre
Kolkata, West Bengal, 700156

Meenakshi Mission Hospital & Research Centre
Madurai, Tamilnadu, 625107

Prince Aly Khan Hospital
Mumbai, Maharashtra, 400010

Tata Memorial Hospital
Mumbai, Maharashtra, 400012

Sahyadri Specialty Hospital
Pune, Maharashtra, 411004

Italy

Azienda Ospedaliera Universitaria “Policlinico – Vittorio Emanuele” (Presidio Ferrarotto Alessi)
Catania, 95124

Azienda Ospedaliera Universitaria Careggi
Firenze, 50134

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
Meldola, Forli – Cesena, 47014

Fondazione IRCCS CA’ Granda Ospedale Maggiore Policlinico
Milano, 2012

Ospedale Sant’Eugenio
Roma, 00144

Azienda Ospedaliera Universitaria Policlinico Umberto I – Università di Roma La
Sapienza
Roma, 00161

Korea, Republic of

Uijeongbu Eulji Medical Center, Eulji University
Gyeonggi-do, Korea, Republic of, 11759

The Catholic University of Korea
Seoul St. Mary’s Hospital
Seoul, Gyeonggi-do, 06591

Romania

Spitalul Clinic Colentina
Bucuresti, 20125

Spitalul Clinic Coltea
Bucuresti, 030171

Institutul Oncologic “Prof. Dr. Ion Chiricuta” Cluj-Napoca
Cluj-Napoca, 400124

Spitalul Clinic Municipal Filantropia Craiova
Craiova, 200143

Spitalul Clinic Judetean de Urgenta Targu Mures
Târgu Mureș, 540136

Singapore

Singapore General Hospital
Singapore, 169856

Spain

ICO Badalona – Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916

Hospital Universitari Vall d’Hebron
Barcelona, 08035

Hospital Universitario 12 de Octubre
Madrid, 28041

Hospital Universitario La Paz
Madrid, 28046

Hospital Universitario Ramon y Cajal
Madrid, 28034

Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010

Hospital Universitario Virgen del Rocio
Sevilla, 41013

Turkey

Hacettepe University Hospital
Altındağ, Turkey, 06230

Kayseri Erciyes University Hospital
Kayseri, Turkey, 38039

United Kingdom

King’s College Hospital
London, Greater London, SE5 9NU

Hammersmith Hospital
London, Greater London, W120HS

United States

California

The Oncology Institute of Hope and Innovation, Innovative Clinical Research
Institute
Downey, California, 90241

University of Southern California
Los Angeles, California, 90033

UCLA Hematologic Malignancy Program
Los Angeles, California, 90024

Florida

Mayo Clinic
Jacksonville, Florida, 32224

Georgia

Board of Regents of the University System of Georgia
Augusta, Georgia, 30912

Indiana

Indiana Blood Marro Transplant
Indianapolis, Indiana, 46237

New York

Memorial Sloan Kettering Cancer Center – MAIN
New York, New York, 10065

New York Medical College
Valhalla, New York, 10595

North Carolina

East Carolina University
Greenville, North Carolina, 27858

Texas

Baylor University Medical Center
Dallas, Texas, 75226

MD Anderson Cancer Center
Houston, Texas, 77030

Utah

Huntsman Cancer Institute University of Utah
Salt Lake City, Utah, 84112