Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment of Ph+ CML Resistant/Intolerant to ≥3 Prior CML Therapies

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

June 27, 2016

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
Healthy (For Part A)Chronic Myeloid Leukemia (for Part B and C)
Interventions
DRUG

Vodobatinib (K0706) capsules

"Part A: Vodobatinib (K0706) capsules in single ascending doses.~Part B: Oral Vodobatinib (K0706) capsules in multiple ascending doses, once daily.~Part C: Oral Vodobatinib (K0706) capsules at recommended phase 2 dose of 174 mg, once daily."

Trial Locations (38)

1200

Cliniques Universitaires Saint-Luc, Brussels

4032

Debreceni Egyetem, Debrecen

6591

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

10065

Memorial Sloan Kettering Cancer Center - MAIN, New York

11759

Uijeongbu Eulji Medical Center, Eulji University, Gyeonggi-do

13273

Institut Paoli Calmettes, Marseille

20122

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Milan

20900

Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), Monza

28034

Hospital Universitario Ramon y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

30912

Board of Regents of the University System of Georgia, Augusta

32224

Mayo Clinic, Jacksonville

38039

Kayseri Erciyes University Hospital, Kayseri

47014

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori, Meldola

69373

Centre Léon Bérard, Lyon

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

75226

Baylor University Medical Center, Dallas

77030

MD Anderson Cancer Center, Houston

84112

Huntsman Cancer Institute University of Utah, Salt Lake City

90024

UCLA Hematologic Malignancy Program, Los Angeles

90241

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

200143

Spitalul Clinic Municipal Filantropia Craiova, Craiova

400010

Prince Aly Khan Hospital, Mumbai

400012

Tata Memorial Hospital, Mumbai

400124

"Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca", Cluj-Napoca

411004

Sahyadri Specialty Hospital, Pune

625107

Meenakshi Mission Hospital & Research Centre, Madurai

700156

Tata Medical Centre, Kolkata

00144

Ospedale Sant'Eugenio, Roma

00161

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

020125

Spitalul Clinic Colentina, Bucharest

06591

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

08916

ICO Badalona - Hospital Universitari Germans Trias i Pujol, Badalona

08035

Hospital Universitari Vall d'Hebron, Barcelona

06230

Hacettepe University Hospital, Altındağ

SE5 9NU

King's College Hospital, London

W120HS

Hammersmith Hospital, London

All Listed Sponsors
lead

Sun Pharma Advanced Research Company Limited

INDUSTRY

NCT02629692 - Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment of Ph+ CML Resistant/Intolerant to ≥3 Prior CML Therapies | Biotech Hunter | Biotech Hunter