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New hope for tough leukemias? trial of vodobatinib begins, then stops

NCT ID NCT02629692

Disease control Sponsor: Sun Pharma Advanced Research Company Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new drug called Vodobatinib (K0706) in people with chronic myeloid leukemia or a related leukemia who had not responded to at least three other treatments. The trial was split into parts: first in healthy volunteers to check safety, then in patients to find the right dose and see if it could shrink cancer cells. Unfortunately, the trial was terminated early, so we have less information than hoped.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vodobatinib (K0706) capsules
What this could lead to
If it works, this could offer a new treatment option for people with CML or Ph+ ALL who have not responded to other therapies.
What could go wrong
The trial was terminated early, so results are limited. It is an early-phase study, so safety and effectiveness are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

124 people

The number who actually took part.

Started

Jun 2016

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Part A Inclusion Criteria: * Healthy males aged 18 to 55 years Part B Key Inclusion Criteria: * Subjects diagnosed with Ph+ CML-CP, Ph+ CML-AP, Ph+ CML-BP, or Ph+ ALL who are refractory or intolerant to at least 3 TKIs or are not eligible (e.g.: due to comorbidities, hypersensitivity to excipients, lack of insurance coverage) for their local country's regulatory approved and medically appropriate TKIs (e.g., a TKI that is effective against mutations in the patient's tumor). Part C Key Inclusion Criteria: * 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 (Subjects with Ph+ ALL are not included). Part B and C: Other 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 Part A Exclusion Criteria: * 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: HIV, hepatitis B surface antigen, or hepatitis C virus * Known or suspected history of significant drug abuse as judged by the Investigator Part B and C Exclusion Criteria: * Presence of T315I * 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

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Conditions

The condition(s) this trial relates to.

chronic myelogenous leukemia, BCR-ABL1 positive leukemia, acute lymphocytic, susceptibility to, 1 Leukemia, Myelogenous, Chronic, BCR-ABL Positive

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic myeloid leukemia (for part B and C) Healthy (for part A)

Contacts and locations

Locations

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

    Roma, 00161, Italy

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

    Monza, Milano, 20900, Italy

  • Baylor University Medical Center

    Dallas, Texas, 75226, United States

  • Board of Regents of the University System of Georgia

    Augusta, Georgia, 30912, United States

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Rhone, 69495, France

  • Centre Léon Bérard

    Lyon, Rhone, 69373, France

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Debreceni Egyetem

    Debrecen, 4032, Hungary

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Hammersmith Hospital

    London, Greater London, W120HS, United Kingdom

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Huntsman Cancer Institute University of Utah

    Salt Lake City, Utah, 84112, United States

  • ICO Badalona - Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Institut Paoli Calmettes

    Marseille, Bouches-du-Rhône, 13273, France

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

    Cluj-Napoca, 400124, Romania

  • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

    Meldola, Forli - Cesena, 47014, Italy

  • King's College Hospital

    London, Greater London, SE5 9NU, United Kingdom

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Meenakshi Mission Hospital & Research Centre

    Madurai, Tamil Nadu, 625107, India

  • Memorial Sloan Kettering Cancer Center - MAIN

    New York, New York, 10065, United States

  • Ospedale Sant'Eugenio

    Roma, 00144, Italy

  • Prince Aly Khan Hospital

    Mumbai, Maharashtra, 400010, India

  • Sahyadri Specialty Hospital

    Pune, Maharashtra, 411004, India

  • Spitalul Clinic Colentina

    Bucharest, 020125, Romania

  • Spitalul Clinic Municipal Filantropia Craiova

    Craiova, 200143, Romania

  • Tata Medical Centre

    Kolkata, West Bengal, 700156, India

  • Tata Memorial Hospital

    Mumbai, Maharashtra, 400012, India

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

    Seoul, Gyeonggi-do, 6591, South Korea

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

    Downey, California, 90241, United States

  • UCLA Hematologic Malignancy Program

    Los Angeles, California, 90024, United States

  • Uijeongbu Eulji Medical Center, Eulji University

    Gyeonggi-do, 11759, South Korea

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