CLR_15_03 = Safety and anti-leukemic activity of vodobatinib (K0706) for refractory/intolerant CML [Asia, Europe, USA]
Type of study
Trials after therapy failure or intolerance
Phase
Current status
Recruiting
Part A in healthy volunteers: completed.
Part B – dose escalation and dose expansion study (only in India and Korea): completed
Part C: ongoing globally
Study title
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)
Other trial ID
ClinicalTrials.gov NCT02629692, EudraCT 2016-001754-18
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 sponsor
Sun Pharma Advanced Research Company (SPARC) Limited, India
Scientific lead / contact
Geetanjali Chimote, MBBS, PhD, SPARC
geetanjali.chimote@sparcmail.com
Principal investigator
Jorge Cortes, MD
Georgia Cancer Center
Jorge.cortes@augusta.edu
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