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Trial record 1 of 1 for:    CLR_15_03
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Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment Refractory/Intolerant CML Failing ≥3 Prior CML Therapies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02629692
Recruitment Status : Recruiting
First Posted : December 14, 2015
Last Update Posted : April 28, 2022
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

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

Condition or disease Intervention/treatment Phase
Healthy (For Part A) Chronic Myeloid Leukemia (for Part B and C) Drug: Vodobatinib (K0706) capsules Phase 1 Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 303 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Part A: Single ascending dose in healthy volunteers.

Part B: Multiple ascending dose safety and tolerability study in subjects with CML or Ph + ALL.

Part C: Efficacy and safety study in subjects with treatment refractory CML

Masking: None (Open Label)
Masking Description:

Part B and C: Single arm (Open-label)

Part A: 2 arms: Investigational agent arm and Placebo arm (Double-blind).

Primary Purpose: Treatment
Official 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)
Actual Study Start Date : April 25, 2017
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2026


Arm Intervention/treatment
Experimental: Vodobatinib (K0706) capsules 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.





Primary Outcome Measures :
  1. To determine the Maximum Tolerated Dose (MTD) as determined by frequency of Dose Limiting Toxicities [ Time Frame: Dose Limiting toxicities observed over a 4 week period ]
    PART B

  2. Incidence and severity of treatment emergent AEs as assessed by CTCAE v4.03 [ Time Frame: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706) ]
    PART B

  3. For CML subjects in CP at study entry [ Time Frame: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706) ]
    PART C: Proportion of subjects achieving Major Cytogenetic Response [ defined as complete cytogenetic response (CCyR; 0% Ph+metaphases) or partial cytogenetic response (PCyR; 1-35% Ph+ metaphases)] as assessed by conventional Karyotyping of Bone marrow aspirate

  4. For CML subjects in AP at study entry [ Time Frame: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706) ]
    PART C: Proportion of subjects achieving Major Hematologic Response [ defined as complete hematologic response (CHR) or no evidence of leukemia (NEL)] as assessed by complete blood count of peripheral blood sample

  5. For CML subjects in BP at study entry [ Time Frame: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706) ]
    PART C: Proportion of subjects achieving Major Hematologic Response [defined as complete hematologic response (CHR) or no evidence of leukemia (NEL)] as assessed by complete blood count of peripheral blood sample


Secondary Outcome Measures :
  1. Pharmacokinetic profile of K0706 - Cmax [The maximum (peak) observed drug concentration after dose administration] [ Time Frame: All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706) ]
    PART B and PART C

  2. Pharmacokinetic profile of Vodobatinib (K0706) - Tmax [The time to reach maximum (peak) drug concentration after dose administration] [ Time Frame: All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706) ]
    PART B and PART C

  3. Pharmacokinetic profile of Vodobatinib (K0706) - Cmin [ Minimum observed drug concentration after dose administration] [ Time Frame: All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706) ]
    PART B and PART C

  4. In subjects with CML- CP:Proportion of subjects achieving Complete Hematological Response as assessed by complete blood count of peripheral blood sample [ Time Frame: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706) ]
    PART C

  5. In subjects with CML- CP:Proportion of subjects achieving Complete Cytogenetic Response as assessed by conventional Karyotyping of Bone marrow aspirate [ Time Frame: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706) ]
    PART C

  6. In subjects with CML- CP:Proportion of subjects achieving Major Molecular Response as assessed by BCR-ABL transcript levels (BCR-ABL1 ratio of ≤ 0.1%) in peripheral blood using PCR (Polymerase Chain Reaction) [ Time Frame: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706) ]
    PART C

  7. In subjects with CML-AP & BP: Proportion of subjects achieving Complete cytogenetic response as assessed by conventional Karyotyping of Bone marrow aspirate [ Time Frame: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706) ]
    PART C

  8. In subjects with CML-AP & BP: Proportion of subjects achieving Partial Cytogenetic Response (PCyR) as assessed by conventional Karyotyping of Bone marrow aspirate [ Time Frame: All subjects will be followed up for 60 months from the first dose of K0706 ]
    Part C

  9. In subjects with CML-AP & BP: Proportion of subjects achieving Major Molecular Response as assessed by BCR-ABL transcript levels (BCR-ABL1 ratio of ≤ 0.1%) in peripheral blood using PCR (Polymerase Chain Reaction) [ Time Frame: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706) ]
    PART C

  10. Time to Major Cytogenetic Response (MCyR): Time to MCyR is the time from first dose to first MCyR (0-35% Ph+ metaphases) ; computed only for subjects who achieved MCyR [ Time Frame: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706) ]
    PART C

  11. Time to Major Molecular Response : Time to MMR is the time from first dose to first MMR (BCR-ABL1 ratio of ≤ 0.1%) computed only for subjects who achieved MMR [ Time Frame: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706) ]
    PART C

  12. In all subjects Progression free survival (PFS) [ Time Frame: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706) ]
    PART C

  13. In all subjects Overall survival (OS) [ Time Frame: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706) ]
    PART C

  14. Incidence and severity of treatment emergent AEs as assessed by CTCAE v5.0 [ Time Frame: All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706) ]
    PART C



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02629692


Contacts
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Contact: Head, Clinical development +9122 66455645 ext 5678 clinical.trials@sparcmail.com

Locations
Hide Hide 70 study locations
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United States, California
The Oncology Institute of Hope and Innovation, Innovative Clinical Research Institute Recruiting
Downey, California, United States, 90241
Contact: Richy Agajanian         
UCLA Hematologic Malignancy Program Not yet recruiting
Los Angeles, California, United States, 90024
Contact: Wanxing Chai-Ho         
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: George Yaghmour         
United States, Florida
Mayo Clinic Not yet recruiting
Jacksonville, Florida, United States, 32224
Contact: Talha Badar         
United States, Georgia
Board of Regents of the University System of Georgia Recruiting
Augusta, Georgia, United States, 30912
Contact: Jorge Cortes         
United States, Indiana
IU Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Hamid Sayar         
Indiana Blood Marro Transplant Not yet recruiting
Indianapolis, Indiana, United States, 46237
Contact: Luke P Akard         
United States, New Jersey
Hackensack University Medical Center Not yet recruiting
Hackensack, New Jersey, United States, 07601
Contact: James McCloskey         
United States, New York
Memorial Sloan Kettering Cancer Center - MAIN Completed
New York, New York, United States, 10065
New York Medical College Withdrawn
Valhalla, New York, United States, 10595
United States, North Carolina
East Carolina University Recruiting
Greenville, North Carolina, United States, 27858
Contact: Darla Liles         
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75226
Contact: Andrew Whiteley         
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Yesid Alvarado-Valero         
United States, Utah
Huntsman Cancer Institute University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Michael Deininger         
Belgium
ZNA Stuivenberg Recruiting
Antwerpen, Belgium, 2060
Contact: Nikki Granacher         
Cliniques Universitaires Saint-Luc Recruiting
Bruxelles, Belgium, 1200
Contact: Violaine Havelange         
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Peter Vandenberghe         
France
Institut Paoli Calmettes Recruiting
Marseille Cedex 9, Bouches-du-Rhône, France, 13273
Contact: Aude Charbonnier         
Institut Bergonié Withdrawn
Bordeaux cedex, Gironde, France, 33076
CHU de Limoges - Hôpital Dupuytren Recruiting
Limoges cedex, Haute Vienne, France, 87042
Contact: Pascal Turlure         
CHU Rennes - Hopital Pontchaillou Recruiting
Rennes cedex 9, Ille Et Vilaine, France, 35033
Contact: Martine Escoffre-Barbe         
CHU de Nantes - Hotel Dieu Recruiting
Nantes cedex 1, Loire Atlantique, France, 44000
Contact: Viviane Dubruille         
CHU Angers - Hôpital Hôtel Dieu Recruiting
Angers, Maine Et Loire, France, 49033
Contact: Mathilde Hunault         
CHU de Nancy - Hôpital de Brabois Adultes Recruiting
Vandœuvre-lès-Nancy, Meurthe Et Moselle, France, 54511
Contact: Agnès Guerci-Bresler         
Hopital Claude Huriez - CHRU Lille Recruiting
Lille cedex, Nord, France, 59037
Contact: Valérie Coiteux         
Hôpital Saint-Louis Recruiting
Paris cedex 10, Paris, France, 75475
Contact: Delphine Rea         
Centre Léon Bérard Recruiting
Lyon Cedex 08, Rhone, France, 69373
Contact: Franck Nicolini         
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         
CHU Amiens - Hopital Sud Withdrawn
Salouel, Somme, France, 80480
CHU Poitiers - Hôpital la Milétrie Withdrawn
Poitiers, Vienne, France, 86021
Hungary
Semmelweis Egyetem Recruiting
Budapest, Hungary, 1083
Contact: Zsolt Nagy         
Debreceni Egyetem Recruiting
Debrecen, Hungary, 4032
Contact: Arpad Illes         
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz Recruiting
Nyiregyhaza, Hungary, 4400
Contact: Laszlo Rejto         
Pecsi Tudomanyegyetem Recruiting
Pecs, Hungary, 7624
Contact: Hussain Alizadeh         
India
Prince Aly Khan Hospital Completed
Mumbai, Maharashtra, India, 400010
Tata Memorial Hospital Completed
Mumbai, Maharashtra, India, 400012
Sahyadri Specialty Hospital Completed
Pune, Maharashtra, India, 411004
Meenakshi Mission Hospital & Research Centre Completed
Madurai, Tamilnadu, India, 625107
Chittaranjan National Cancer Institute Withdrawn
Kolkata, West Bengal, India, 700026
Tata Medical Centre Completed
Kolkata, West Bengal, India, 700156
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 di Monza (Presidio San Gerardo) Recruiting
Monza, Milano, Italy, 20900
Contact: Carlo Gambacorti Passerini         
Azienda Ospedaliera Universitaria "Policlinico - Vittorio Emanuele" (Presidio Ferrarotto Alessi) Recruiting
Catania, Italy, 95124
Contact: Fabio Stagno         
Azienda Ospedaliera Universitaria Careggi Recruiting
Firenze, Italy, 50134
Contact: Barbara Scappini         
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico Recruiting
Milano, Italy, 20122
Contact: Alessandra Iurlo         
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) Recruiting
Milano, Italy, 20162
Contact: Ester Pungolino         
Ospedale Sant'Eugenio Recruiting
Roma, Italy, 00144
Contact: Elisabetta Abruzzese         
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza Recruiting
Roma, Italy, 00161
Contact: Martelli Maurizio         
Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital Completed
Seoul, Gyeonggi-do, Korea, Republic of, 06591
The Catholic University of Korea, Seoul St. Mary's Hospital Completed
Seoul, Gyeonggi-do, Korea, Republic of, 6591
Uijeongbu Eulji Medical Center, Eulji University Recruiting
Gyeonggi-do, Korea, Republic of, 11759
Contact: Dong-Wook Kim         
Romania
Spitalul Clinic Colentina Recruiting
Bucuresti, Romania, 020125
Contact: Viola-Maria Popov         
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 Municipal Filantropia Craiova Recruiting
Craiova, Romania, 200143
Contact: Luminita Ocroteala         
Spitalul Clinic Judetean de Urgenta Targu Mures Recruiting
Târgu Mureș, Romania, 540136
Contact: Ioan Macarie         
Singapore
Singapore General Hospital Withdrawn
Singapore, Singapore, 169856
Spain
ICO Badalona - Hospital Universitari Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Blanca Xicoy         
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Guillermo Ortí         
ICO Girona - Hospital Universitari de Girona Dr Josep Trueta Recruiting
Girona, Spain, 17007
Contact: Anna Angona Figueras         
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Contact: Valentín García Gutiérrez         
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 Clinico Universitario Virgen de la Victoria Recruiting
Málaga, Spain, 29010
Contact: Regina Garcia         
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
Contact: Fermin Sanchez-Guijo         
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain, 41009
Contact: Juan Antonio Vera Goñi         
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Contact: Isabel Montero Cuadrado,         
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         
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
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Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT02629692    
Other Study ID Numbers: CLR_15_03 V 12 Amendment 12
First Posted: December 14, 2015    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sun Pharma Advanced Research Company Limited:
CML
Chronic Myelogenous Leukemia
K0706
Vodobatinib
ponatinib-refractory/intolerant
treatment refractory chronic myeloid leukemia
Ponatinib
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases