Chronic Lymphocytic Leukemia Clinical Trial

Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment Refractory/Intolerant CML Failing ≥3 Prior CML Therapies

Summary

Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML

View Full Description

Full Description

Part A ( for Healthy volunteers) of the study is completed

Part B dose-escalation study is completed. Recruitment in dose-expansion is ongoing in India and Korea

Part C study in subjects with treatment-refractory/intolerant is enrolling globally.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Willing and able to give written, and dated, informed consent
Male or female aged ≥ 18 years
Willing and able to comply with the scheduled visits
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Subjects 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 (Part C).

Exclusion Criteria:

Presence of T315I (PART C)
Any major surgery, as determined by the Investigator, within 4 weeks of IMP administration
Inability to undergo venipuncture and/or tolerate venous access
Positive exclusion tests: urine pregnancy tests (if applicable), HIV, hepatitis B surface antigen, or hepatitis C virus
Known or suspected history of significant drug abuse as judged by the Investigator
Received any other investigational agent within 30 days or a washout of at least 5 half-lives, whichever is longer of IMP administration
Subjects who are eligible for potentially curative therapy that is available, including hematopoietic stem cell transplant
Another primary malignancy within the past 3 years or earlier (except for adequately treated non-melanoma skin cancer or cervical cancer in situ

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

303

Study ID:

NCT02629692

Recruitment Status:

Recruiting

Sponsor:

Sun Pharma Advanced Research Company Limited

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There are 69 Locations for this study

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The Oncology Institute of Hope and Innovation, Innovative Clinical Research Institute
Downey California, 90241, United States More Info
Richy Agajanian
Contact
UCLA Hematologic Malignancy Program
Los Angeles California, 90024, United States More Info
Wanxing Chai-Ho
Contact
University of Southern California
Los Angeles California, 90033, United States More Info
George Yaghmour
Contact
Mayo Clinic
Jacksonville Florida, 32224, United States More Info
Talha Badar
Contact
Board of Regents of the University System of Georgia
Augusta Georgia, 30912, United States More Info
Jorge Cortes
Contact
IU Simon Cancer Center
Indianapolis Indiana, 46202, United States More Info
Hamid Sayar
Contact
Indiana Blood Marro Transplant
Indianapolis Indiana, 46237, United States More Info
Luke P Akard
Contact
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States More Info
James McCloskey
Contact
Memorial Sloan Kettering Cancer Center - MAIN
New York New York, 10065, United States
New York Medical College
Valhalla New York, 10595, United States
East Carolina University
Greenville North Carolina, 27858, United States More Info
Darla Liles
Contact
Baylor University Medical Center
Dallas Texas, 75226, United States More Info
Andrew Whiteley
Contact
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Yesid Alvarado-Valero
Contact
Huntsman Cancer Institute University of Utah
Salt Lake City Utah, 84112, United States More Info
Michael Deininger
Contact
ZNA Stuivenberg
Antwerpen , 2060, Belgium More Info
Nikki Granacher
Contact
Cliniques Universitaires Saint-Luc
Bruxelles , 1200, Belgium More Info
Violaine Havelange
Contact
UZ Leuven
Leuven , 3000, Belgium More Info
Peter Vandenberghe
Contact
Institut Paoli Calmettes
Marseille Cedex 9 Bouches-du-Rhône, 13273, France More Info
Aude Charbonnier
Contact
Institut Bergonié
Bordeaux cedex Gironde, 33076, France
CHU de Limoges - Hôpital Dupuytren
Limoges cedex Haute Vienne, 87042, France More Info
Pascal Turlure
Contact
CHU Rennes - Hopital Pontchaillou
Rennes cedex 9 Ille Et Vilaine, 35033, France More Info
Martine Escoffre-Barbe
Contact
CHU de Nantes - Hotel Dieu
Nantes cedex 1 Loire Atlantique, 44000, France More Info
Viviane Dubruille
Contact
CHU Angers - Hôpital Hôtel Dieu
Angers Maine Et Loire, 49033, France More Info
Mathilde Hunault
Contact
CHU de Nancy - Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy Meurthe Et Moselle, 54511, France More Info
Agnès Guerci-Bresler
Contact
Hopital Claude Huriez - CHRU Lille
Lille cedex Nord, 59037, France More Info
Valérie Coiteux
Contact
Hôpital Saint-Louis
Paris cedex 10 Paris, 75475, France More Info
Delphine Rea
Contact
Centre Léon Bérard
Lyon Cedex 08 Rhone, 69373, France More Info
Franck Nicolini
Contact
Centre Hospitalier Lyon Sud
Pierre-Bénite Rhone, 69495, France More Info
Xavier Thomas
Contact
Hôpital Avicenne
Bobigny cedex Seine Saint Denis, 93009, France More Info
Thorsten Braun
Contact
CHU Amiens - Hopital Sud
Salouel Somme, 80480, France
CHU Poitiers - Hôpital la Milétrie
Poitiers Vienne, 86021, France
Semmelweis Egyetem
Budapest , 1083, Hungary More Info
Zsolt Nagy
Contact
Debreceni Egyetem
Debrecen , 4032, Hungary More Info
Arpad Illes
Contact
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyiregyhaza , 4400, Hungary More Info
Laszlo Rejto
Contact
Pecsi Tudomanyegyetem
Pecs , 7624, Hungary More Info
Hussain Alizadeh
Contact
Prince Aly Khan Hospital
Mumbai Maharashtra, 40001, India
Tata Memorial Hospital
Mumbai Maharashtra, 40001, India
Sahyadri Specialty Hospital
Pune Maharashtra, 41100, India
Meenakshi Mission Hospital & Research Centre
Madurai Tamilnadu, 62510, India
Chittaranjan National Cancer Institute
Kolkata West Bengal, 70002, India
Tata Medical Centre
Kolkata West Bengal, 70015, India
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
Meldola Forli - Cesena, 47014, Italy More Info
Alessandro Lucchesi
Contact
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
Monza Milano, 20900, Italy More Info
Carlo Gambacorti Passerini
Contact
Azienda Ospedaliera Universitaria "Policlinico - Vittorio Emanuele" (Presidio Ferrarotto Alessi)
Catania , 95124, Italy More Info
Fabio Stagno
Contact
Azienda Ospedaliera Universitaria Careggi
Firenze , 50134, Italy More Info
Barbara Scappini
Contact
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milano , 20122, Italy More Info
Alessandra Iurlo
Contact
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milano , 20162, Italy More Info
Ester Pungolino
Contact
Ospedale Sant'Eugenio
Roma , 00144, Italy More Info
Elisabetta Abruzzese
Contact
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
Roma , 00161, Italy More Info
Martelli Maurizio
Contact
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul Gyeonggi-do, 06591, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul Gyeonggi-do, 6591, Korea, Republic of
Uijeongbu Eulji Medical Center, Eulji University
Gyeonggi-do , 11759, Korea, Republic of More Info
Dong-Wook Kim
Contact
Spitalul Clinic Colentina
Bucuresti , 02012, Romania More Info
Viola-Maria Popov
Contact
Spitalul Clinic Coltea
Bucuresti , 03017, Romania More Info
Gabriela Borsaru
Contact
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
Cluj-Napoca , 40012, Romania More Info
Delia Dima
Contact
Spitalul Clinic Municipal Filantropia Craiova
Craiova , 20014, Romania More Info
Luminita Ocroteala
Contact
Spitalul Clinic Judetean de Urgenta Targu Mures
Târgu Mureș , 54013, Romania More Info
Ioan Macarie
Contact
Singapore General Hospital
Singapore , 16985, Singapore
ICO Badalona - Hospital Universitari Germans Trias i Pujol
Badalona Barcelona, 08916, Spain More Info
Blanca Xicoy
Contact
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain More Info
Guillermo Ortí
Contact
ICO Girona - Hospital Universitari de Girona Dr Josep Trueta
Girona , 17007, Spain More Info
Anna Angona Figueras
Contact
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain More Info
Valentín García Gutiérrez
Contact
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain More Info
Rosa Ayala Diaz
Contact
Hospital Universitario La Paz
Madrid , 28046, Spain More Info
Raquel de Paz Arias
Contact
Hospital Clinico Universitario Virgen de la Victoria
Málaga , 29010, Spain More Info
Regina Garcia
Contact
Hospital Universitario de Salamanca
Salamanca , 37007, Spain More Info
Fermin Sanchez-Guijo
Contact
Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain More Info
Juan Antonio Vera Goñi
Contact
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain More Info
Isabel Montero Cuadrado,
Contact
King's College Hospital
London Greater London, SE5 9, United Kingdom More Info
de Lavallade Hugues
Contact
Hammersmith Hospital
London Greater London, W120H, United Kingdom More Info
Jane Apperley
Contact

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

303

Study ID:

NCT02629692

Recruitment Status:

Recruiting

Sponsor:


Sun Pharma Advanced Research Company Limited

How clear is this clinincal trial information?

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