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

Study title

Safety and anti-leukemic activity of vodobatinib (K0706) for treatment of refractory/intolerant CML failing 3 or more prior CML therapies

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 an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2
- have adequate organ and immune system function
- 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.

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. 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).

Type of study

2. Trials after therapy failure or intolerance

Current status

Recruiting

Part A in healthy volunteers: Completed.
Part B: Dose escalation completed, dose expansion study nearing completion (open only in India and Korea)
Part C: Ongoing globally in all countriesf study in subjects with CML is on-going in all mentioned countries except India.

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

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

UZ Leuven
[Recruiting]
Leuven, Belgium, 3000
Contact: Peter Vandenberghe

ZNA Stuivenberg
[Recruiting]
Antwerpen, Belgium, 2060
Contact: Nikki Granacher

Cliniques Universitaires Saint-Luc
[Recruiting]
Bruxelles, Belgium, 1200
Contact: Violaine Havelange

France

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

Centre Hospitalier Lyon Sud
[Recruiting]
Pierre-Bénite, Rhone, France, 69495
Contact: Xavier Thomas

Hôpital Avicenne
[Recruiting]
Bobigny cedex, Seine Saint Denis, France, 93009
Contact: Thorsten Braun

Hopital Claude Huriez - CHRU Lille
[Recruiting]
Lille cedex, Nord, France, 59037
Contact: Valérie Coiteux

CHU de Nantes - Hotel Dieu
[Recruiting]
Nantes cedex 1, Loire Atlantique, France, 44000
Contact: Viviane Dubruille

CHU Rennes - Hopital Pontchaillou
[Recruiting]
Rennes cedex 9, Ille Et Vilaine, France, 35033
Contact: Martine Escoffre-Barbe

Institut Bergonié
[Recruiting]
Bordeaux cedex, Gironde, France, 33076
Contact: Gabriel Etienne

Centre Léon Bérard
[Recruiting]
Lyon Cedex 08, Rhone, France, 69373
Contact: Franck Nicolini

Hôpital Saint-Louis
[Recruiting]
Paris cedex 10, Paris, France, 75475
Contact: Delphine Rea

CHU Poitiers - Hôpital la Milétrie
[Recruiting]
Poitiers, Vienne, France, 86021
Contact: Emilie Cayssials

CHU Amiens - Hopital Sud
[Not yet recruiting]
Salouel, Somme, France, 80480
Contact: Gouin Charbonnier

CHU de Nancy - Hôpital de Brabois Adultes
[Recruiting]
Vandoeuvre-lès-Nancy, Meurthe Et Moselle, France, 54511
Contact: Agnès Guerci-Bresler

CHU Angers - Hôpital Hôtel Dieu
[Recruiting]
Angers, Maine Et Loire, France, 49033
Contact: Mathilde Hunault

CHU de Limoges - Hôpital Dupuytren
[Recruiting]
Limoges cedex, Haute Vienne, France, 87042
Contact: Pascal Turlure

Hungary

Pecsi Tudomanyegyetem
[Recruiting]
Pecs, Hungary, 7624
Contact: Hussain Alizadeh

Semmelweis Egyetem
[Recruiting]
Budapest, Hungary, 1083
Contact: Zsolt Nagy

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
[Recruiting]
Nyiregyhaza, Hungary, 4400
Contact: Laszlo Rejto

Debreceni Egyetem
[Recruiting]
Debrecen, Hungary, 4032
Contact: Arpad Illes

India

Prince Aly Khan Hospital
[Recruiting]
Mumbai, Maharashtra, India, 400010
Contact: Tapan Saikia

Chittaranjan National Cancer Institute
[Recruiting]
Kolkata, West Bengal, India, 700026
Contact: Kalyan Mukherjee

Meenakshi Mission Hospital & Research Centre
[Recruiting]
Madurai, Tamilnadu, India, 625107
Contact: Krishna Rathnam

Tata Memorial Hospital
[Recruiting]
Mumbai, Maharashtra, India, 400012
Contact: Navin Khattry

Sahyadri Specialty Hospital
[Recruiting]
Pune, Maharashtra, India, 411004
Contact: Shashikant J Apte

Tata Medical Centre
[Recruiting]
Kolkata, West Bengal, India, 700156
Contact: Vivek S Radhakrishnan


Italy

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
[Recruiting]
Meldola, Forli - Cesena, Italy, 47014
Contact: Alessandro Lucchesi

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

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

Ospedale Sant'Eugenio
[Recruiting]
Roma, Italy, 00144
Contact: Elisabetta Abruzzese

Azienda Ospedaliera Universitaria Careggi
[Not yet recruiting]
Firenze, Italy, 50134
Contact: Barbara Scappini

Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La
Sapienza
[Not yet recruiting]
Roma, Italy, 00161
Contact: Martelli

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
[Recruiting]
Milano, Italy, 20122
Contact: Alessandra Iurlo

Azienda Ospedaliera Universitaria "Policlinico - Vittorio Emanuele" (Presidio
Ferrarotto Alessi)
[Recruiting]

Catania, Italy, 95124
Contact: Fabio Stagno


Romania

Spitalul Clinic Coltea
[Recruiting]
Bucuresti, Romania, 030171
Contact: Gabriela Borsaru

Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
[Recruiting]
Cluj-Napoca, Romania, 400124
Contact: Delia Dima

Spitalul Clinic Judetean de Urgenta Targu Mures
[Recruiting]
Târgu Mure#, Romania, 540136
Contact: Ioan Macarie

Spitalul Clinic Colentina
[Recruiting]
Bucuresti, Romania, 020125
Contact: Viola-Maria Popov

Spitalul Clinic Municipal Filantropia Craiova
[Recruiting]
Craiova, Romania, 200143
Contact: Luminita Ocroteala

Singapore

Singapore General Hospital
[Not yet recruiting]
Singapore, Singapore, 169856
Contact: Thuan Heng Charles Chuah


South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital
[Not yet recruiting]
Seoul, Gyeonggi-do, South Korea, 06591
Contact: Dong-Wook Kim


Spain

Hospital Universitario 12 de Octubre
[Recruiting]
Madrid, Spain, 28041
Contact: Rosa Ayala Diaz

Hospital Universitario La Paz
[Recruiting]
Madrid, Spain, 28046
Contact: Raquel de Paz Arias

Hospital Universitario Ramon y Cajal
[Recruiting]
Madrid, Spain, 28034
Contact: Valentín García Gutiérrez

Hospital Universitario Virgen del Rocio
[Recruiting]
Sevilla, Spain, 41013
Contact: Isabel Montero Cuadrado,

Hospital Universitari Vall d'Hebron
[Recruiting]
Barcelona, Spain, 08035
Contact: Guillermo Ortí

Hospital Universitario de Salamanca
[Recruiting]
Salamanca, Spain, 37007
Contact: Fermin Sanchez-Guijo

ICO Badalona - Hospital Universitari Germans Trias i Pujol
[Recruiting]
Badalona, Barcelona, Spain, 08916
Contact: Blanca Xicoy

ICO Girona - Hospital Universitari de Girona Dr Josep Trueta
[Recruiting]
Girona, Spain, 17007
Contact: Anna Angona Figueras

Hospital Clinico Universitario Virgen de la Victoria
[Not yet recruiting]
Málaga, Spain, 29010
Contact: Regina Garcia

Hospital Universitario Virgen Macarena
[Recruiting]
Sevilla, Spain, 41009
Contact: Juan Antonio Vera Goñi


United Kingdom

King's College Hospital
[Recruiting]
London, Greater London, United Kingdom, SE5 9NU
Contact: de Lavallade Hugues

Hammersmith Hospital
[Recruiting]
London, Greater London, United Kingdom, W120HS
Contact: Jane Apperley

United States

United States, California
University of Southern California
[Recruiting]
Los Angeles, California, United States, 90033
Contact: George Yaghmour

United States, Texas
MD Anderson Cancer Center
[Recruiting]
Houston, Texas, United States, 77030
Contact: Yesid Alvarado-Valero

United States, New York
New York Medical College
[Not yet recruiting]
Valhalla, New York, United States, 10595
Contact: Karen Seiter

United States, New York
Memorial Sloan Kettering Cancer Center - MAIN
[Active, not recruiting]
New York, New York, United States, 10065
Contact: Mauro Michael

United States, California
The Oncology Institute of Hope and Innovation, Innovative Clinical Research
Institute
[Recruiting]
Downey, California, United States, 90241
Contact: Richy Agajanian

United States, Utah
Huntsman Cancer Institute University of Utah
[Recruiting]
Salt Lake City, Utah, United States, 84112
Contact: Michael Deininger

United States, North Carolina
East Carolina University
[Not yet recruiting]
Greenville, North Carolina, United States, 27858
Contact: Darla Liles

United States, Indiana
IU Simon Cancer Center
[Recruiting]
Indianapolis, Indiana, United States, 46202
Contact: Hamid Sayar

United States, Georgia
Board of Regents of the University System of Georgia
[Recruiting]
Augusta, Georgia, United States, 30912
Contact: Jorge Cortes

United States, Texas
Baylor University Medical Center
[Recruiting]
Dallas, Texas, United States, 75226
Contact: Andrew Whiteley

United States, California
UCLA Hematologic Malignancy Program
[Not yet recruiting]
Los Angeles, California, United States, 90024
Contact: Wanxing Chai-Ho

United States, New Jersey
Hackensack University Medical Center
[Not yet recruiting]
Hackensack, New Jersey, United States, 07601
Contact: James McCloskey

 


 
   
 

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