CLR_15_03 = Safety and anti-leukemic activity of vodobatinib (K0706) for refractory/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

ZNA Stuivenberg
Antwerpen, 2060
Contact: Nikki Granacher

Cliniques Universitaires Saint-Luc
Bruxelles, 1200
Contact: Violaine Havelange

UZ Leuven
Leuven, 3000
Contact: Peter Vandenberghe

France

CHU Angers – Hôpital Hôtel Dieu
Angers, Maine Et Loire, 49033
Contact: Mathilde Hunault

Hôpital Avicenne
Bobigny cedex, Seine Saint Denis, 93009
Contact: Thorsten Braun

Hopital Claude Huriez – CHRU Lille
Lille cedex, Nord, 59037
Contact: Valérie Coiteux

CHU de Limoges – Hôpital Dupuytren
Limoges cedex, Haute Vienne, 87042
Contact: Pascal Turlure

Centre Léon Bérard
Lyon Cedex 08, Rhone, 69373
Contact: Franck Nicolini

Institut Paoli Calmettes
Marseille Cedex 9, Bouches-du-Rhône, 13273
Contact: Aude Charbonnier

CHU de Nantes – Hotel Dieu
Nantes cedex 1, Loire Atlantique, 44000
Contact: Viviane Dubruille

Hôpital Saint-Louis
Paris cedex 10, Paris, 75475
Contact: Delphine Rea

Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhone, 69495
Contact: Xavier Thomas

CHU Rennes – Hopital Pontchaillou
Rennes cedex 9, Ille Et Vilaine, 35033
Contact: Martine Escoffre-Barbe

CHU de Nancy – Hôpital de Brabois Adultes
Vandoeuvre-lès-Nancy, Meurthe Et Moselle, 54511
Contact: Agnès Guerci-Bresler

Hungary

Semmelweis Egyetem
Budapest, 1083
Contact: Zsolt Nagy

Debreceni Egyetem
Debrecen, 4032
Contact: Arpad Illes

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyiregyhaza, 4400
Contact: Laszlo Rejto

Pecsi Tudomanyegyetem
Pecs, 7624
Contact: Hussain Alizadeh

India – recruitment completed

Tata Medical Centre
Kolkata, West Bengal, 700156
Contact: Vivek S Radhakrishnan

Chittaranjan National Cancer Institute
Kolkata, West Bengal, 700026

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
Contact: Fabio Stagno

Azienda Ospedaliera Universitaria Careggi
Firenze, 50134
Contact: Barbara Scappini

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

Fondazione IRCCS CA’ Granda Ospedale Maggiore Policlinico
Milano, 20122
Contact: Alessandra Iurlo

Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano
Niguarda)
Milano, 20162
Contact: Ester Pungolino

Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
Monza, Milano, 20900
Contact: Carlo Gambacorti Passerini

Ospedale Sant’Eugenio
Roma, 00144
Contact: Elisabetta Abruzzese

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

Korea, Republic of – recruitment completed

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

Romania

Spitalul Clinic Colentina
Bucuresti, 20125
Contact:Contact: Viola-Maria Popov

Spitalul Clinic Coltea
Bucuresti, 030171
Contact: Gabriela Borsaru

Institutul Oncologic “Prof. Dr. Ion Chiricuta” Cluj-Napoca
Cluj-Napoca, 400124
Contact: Delia Dima

Spitalul Clinic Judetean de Urgenta Targu Mures
Târgu Mures, 540136
Contact: Ioan Macarie

Spitalul Clinic Municipal Filantropia Craiova
Craiova, 200143
Contact: Luminita Ocroteala

Spain

ICO Badalona – Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Contact: Blanca Xicoy

Hospital Universitari Vall d’Hebron
Barcelona, 08035
Contact: Guillermo Ortí

ICO Girona – Hospital Universitari de Girona Dr Josep Trueta
Girona, 17007
Contact: Anna Angona Figueras

Hospital Universitario 12 de Octubre
Madrid, 28041
Contact: Rosa Ayala Diaz

Hospital Universitario La Paz
Madrid, 28046
Contact: Raquel de Paz Arias

Hospital Universitario Ramon y Cajal
Madrid, 28034
Contact: Valentín García Gutiérrez

Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010
Contact: Regina Garcia

Hospital Universitario de Salamanca
Salamanca, 37007
Contact: Fermin Sanchez-Guijo

Hospital Universitario Virgen del Rocio
Sevilla, 41013
Contact: Isabel Montero Cuadrad

Hospital Universitario Virgen Macarena
Sevilla, 41009
Contact: Juan Antonio Vera Goñi

United Kingdom

King’s College Hospital
London, Greater London, SE5 9NU
Contact: de Lavallade Hugues

Hammersmith Hospital
London, Greater London, W120HS
Contact: Jane Apperley

United States

California

The Oncology Institute of Hope and Innovation, Innovative Clinical Research
Institute
Downey, California, 90241
Contact: Richy Agajanian

University of Southern California
Los Angeles, California, 90033
Contact: George Yaghmour

UCLA Hematologic Malignancy Program
Los Angeles, California, 90024
Contact: Wanxing Chai-Ho

Florida

Mayo Clinic
Jacksonville, Florida, 32224
Contact: Talha Badar

Georgia

Board of Regents of the University System of Georgia
Augusta, Georgia, 30912
Contact: Jorge Cortes

Indiana

IU Simon Cancer Center
Indianapolis, Indiana, 46202
Contact: Hamid Sayar

Indiana Blood Marro Transplant
Indianapolis, Indiana, 46237
Contact: Luke P Akard

New Jersey

Hackensack University Medical Center
Hackensack, New Jersey, 07601
Contact: James McCloskey

New York

Memorial Sloan Kettering Cancer Center – MAIN
New York, New York, 10065
Contact: Mauro Michael

North Carolina

East Carolina University
Greenville, North Carolina, 27858
Contact: Darla Liles

Texas

Baylor University Medical Center
Dallas, Texas, 75226
Contact: Andrew Whiteley

MD Anderson Cancer Center
Houston, Texas, 77030
Contact: Yesid Alvarado-Valero

Utah

Huntsman Cancer Institute University of Utah
Salt Lake City, Utah, 84112
Contact: Michael Deininger