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

Primary Purpose

Healthy (For Part A), Chronic Myeloid Leukemia (for Part B and C)

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Vodobatinib (K0706) capsules
Sponsored by
Sun Pharma Advanced Research Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy (For Part A) focused on measuring CML, Chronic Myelogenous Leukemia, K0706, Vodobatinib, ponatinib-refractory/intolerant, treatment refractory chronic myeloid leukemia, Ponatinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Oncology Institute of Hope and Innovation, Innovative Clinical Research Institute
  • UCLA Hematologic Malignancy Program
  • Mayo Clinic
  • Board of Regents of the University System of Georgia
  • Indiana Blood Marro Transplant
  • Memorial Sloan Kettering Cancer Center - MAIN
  • East Carolina University
  • Baylor University Medical Center
  • MD Anderson Cancer Center
  • Huntsman Cancer Institute University of Utah
  • Cliniques Universitaires Saint-Luc
  • Institut Paoli Calmettes
  • CHU Angers - Hôpital Hôtel Dieu
  • CHU de Nancy - Hôpital de Brabois Adultes
  • Hôpital Saint-Louis
  • Centre Léon Bérard
  • Centre Hospitalier Lyon Sud
  • CHU Amiens - Hopital Sud
  • Debreceni Egyetem
  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
  • Pecsi Tudomanyegyetem
  • Prince Aly Khan Hospital
  • Tata Memorial Hospital
  • Sahyadri Specialty Hospital
  • Meenakshi Mission Hospital & Research Centre
  • Tata Medical Centre
  • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
  • Ospedale Sant'Eugenio
  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Uijeongbu Eulji Medical Center, Eulji University
  • Spitalul Clinic Colentina
  • Spitalul Clinic Coltea
  • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
  • Spitalul Clinic Municipal Filantropia Craiova
  • Singapore General Hospital
  • ICO Badalona - Hospital Universitari Germans Trias i Pujol
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario Ramon y Cajal
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital Clinico Universitario Virgen de la Victoria
  • Hospital Universitario Virgen del Rocio
  • Ankara University Hospital
  • Hacettepe University Hospital
  • Bursa Uludag University Hospital
  • Ege University Hospital
  • Kayseri Erciyes University Hospital
  • King's College Hospital
  • Hammersmith Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vodobatinib (K0706) capsules

Arm Description

Outcomes

Primary Outcome Measures

To determine the Maximum Tolerated Dose (MTD) as determined by frequency of Dose Limiting Toxicities
PART B
Incidence and severity of treatment emergent AEs as assessed by CTCAE v4.03
PART B
For CML subjects in CP at study entry
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
For CML subjects in AP at study entry
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
For CML subjects in BP at study entry
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

Pharmacokinetic profile of K0706 - Cmax [The maximum (peak) observed drug concentration after dose administration]
PART B and PART C
Pharmacokinetic profile of Vodobatinib (K0706) - Tmax [The time to reach maximum (peak) drug concentration after dose administration]
PART B and PART C
Pharmacokinetic profile of Vodobatinib (K0706) - Cmin [ Minimum observed drug concentration after dose administration]
PART B and PART C
In subjects with CML- CP:Proportion of subjects achieving Complete Hematological Response as assessed by complete blood count of peripheral blood sample
PART C
In subjects with CML- CP:Proportion of subjects achieving Complete Cytogenetic Response as assessed by conventional Karyotyping of Bone marrow aspirate
PART C
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)
PART C
In subjects with CML-AP & BP: Proportion of subjects achieving Complete cytogenetic response as assessed by conventional Karyotyping of Bone marrow aspirate
PART C
In subjects with CML-AP & BP: Proportion of subjects achieving Partial Cytogenetic Response (PCyR) as assessed by conventional Karyotyping of Bone marrow aspirate
Part C
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)
PART C
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
PART C
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
PART C
In all subjects Progression free survival (PFS)
PART C
In all subjects Overall survival (OS)
PART C
Incidence and severity of treatment emergent AEs as assessed by CTCAE v5.0
PART C

Full Information

First Posted
December 10, 2015
Last Updated
July 19, 2023
Sponsor
Sun Pharma Advanced Research Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02629692
Brief Title
Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment of Ph+ CML Resistant/Intolerant to ≥3 Prior CML Therapies
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharma Advanced Research Company Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML
Detailed Description
Part A ( for Healthy volunteers) of the study is completed. Part B dose-escalation study is completed. Recruitment in dose expansion is completed. Part C study in subjects with treatment-resistant/intolerant is ongoing for the enrolled subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy (For Part A), Chronic Myeloid Leukemia (for Part B and C)
Keywords
CML, Chronic Myelogenous Leukemia, K0706, Vodobatinib, ponatinib-refractory/intolerant, treatment refractory chronic myeloid leukemia, Ponatinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
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-resistant 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).
Allocation
N/A
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vodobatinib (K0706) capsules
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Vodobatinib (K0706) capsules
Intervention Description
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 Measure Information:
Title
To determine the Maximum Tolerated Dose (MTD) as determined by frequency of Dose Limiting Toxicities
Description
PART B
Time Frame
Dose Limiting toxicities observed over a 4 week period
Title
Incidence and severity of treatment emergent AEs as assessed by CTCAE v4.03
Description
PART B
Time Frame
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Title
For CML subjects in CP at study entry
Description
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
Time Frame
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Title
For CML subjects in AP at study entry
Description
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
Time Frame
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Title
For CML subjects in BP at study entry
Description
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
Time Frame
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Secondary Outcome Measure Information:
Title
Pharmacokinetic profile of K0706 - Cmax [The maximum (peak) observed drug concentration after dose administration]
Description
PART B and PART C
Time Frame
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
Title
Pharmacokinetic profile of Vodobatinib (K0706) - Tmax [The time to reach maximum (peak) drug concentration after dose administration]
Description
PART B and PART C
Time Frame
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
Title
Pharmacokinetic profile of Vodobatinib (K0706) - Cmin [ Minimum observed drug concentration after dose administration]
Description
PART B and PART C
Time Frame
All subjects will be followed for up to approximately 60 months after the first dose of Vodobatinib (K0706)
Title
In subjects with CML- CP:Proportion of subjects achieving Complete Hematological Response as assessed by complete blood count of peripheral blood sample
Description
PART C
Time Frame
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Title
In subjects with CML- CP:Proportion of subjects achieving Complete Cytogenetic Response as assessed by conventional Karyotyping of Bone marrow aspirate
Description
PART C
Time Frame
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Title
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)
Description
PART C
Time Frame
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Title
In subjects with CML-AP & BP: Proportion of subjects achieving Complete cytogenetic response as assessed by conventional Karyotyping of Bone marrow aspirate
Description
PART C
Time Frame
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Title
In subjects with CML-AP & BP: Proportion of subjects achieving Partial Cytogenetic Response (PCyR) as assessed by conventional Karyotyping of Bone marrow aspirate
Description
Part C
Time Frame
All subjects will be followed up for 60 months from the first dose of K0706
Title
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)
Description
PART C
Time Frame
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Title
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
Description
PART C
Time Frame
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Title
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
Description
PART C
Time Frame
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Title
In all subjects Progression free survival (PFS)
Description
PART C
Time Frame
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Title
In all subjects Overall survival (OS)
Description
PART C
Time Frame
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)
Title
Incidence and severity of treatment emergent AEs as assessed by CTCAE v5.0
Description
PART C
Time Frame
All subjects will be followed up for 60 months from the first dose of Vodobatinib (K0706)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
The Oncology Institute of Hope and Innovation, Innovative Clinical Research Institute
City
Downey
State/Province
California
ZIP/Postal Code
90241
Country
United States
Facility Name
UCLA Hematologic Malignancy Program
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Board of Regents of the University System of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Indiana Blood Marro Transplant
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center - MAIN
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Huntsman Cancer Institute University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Institut Paoli Calmettes
City
Marseille Cedex 9
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13273
Country
France
Facility Name
CHU Angers - Hôpital Hôtel Dieu
City
Angers
State/Province
Maine Et Loire
ZIP/Postal Code
49033
Country
France
Facility Name
CHU de Nancy - Hôpital de Brabois Adultes
City
Vandœuvre-lès-Nancy
State/Province
Meurthe Et Moselle
ZIP/Postal Code
54511
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris cedex 10
State/Province
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Centre Léon Bérard
City
Lyon Cedex 08
State/Province
Rhone
ZIP/Postal Code
69373
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
State/Province
Rhone
ZIP/Postal Code
69495
Country
France
Facility Name
CHU Amiens - Hopital Sud
City
Salouel
State/Province
Somme
ZIP/Postal Code
80480
Country
France
Facility Name
Debreceni Egyetem
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Prince Aly Khan Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400010
Country
India
Facility Name
Tata Memorial Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Sahyadri Specialty Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Meenakshi Mission Hospital & Research Centre
City
Madurai
State/Province
Tamilnadu
ZIP/Postal Code
625107
Country
India
Facility Name
Tata Medical Centre
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700156
Country
India
Facility Name
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
City
Meldola
State/Province
Forli - Cesena
ZIP/Postal Code
47014
Country
Italy
Facility Name
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Ospedale Sant'Eugenio
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
State/Province
Gyeonggi-do
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
State/Province
Gyeonggi-do
ZIP/Postal Code
6591
Country
Korea, Republic of
Facility Name
Uijeongbu Eulji Medical Center, Eulji University
City
Gyeonggi-do
ZIP/Postal Code
11759
Country
Korea, Republic of
Facility Name
Spitalul Clinic Colentina
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
Facility Name
Spitalul Clinic Coltea
City
Bucuresti
ZIP/Postal Code
030171
Country
Romania
Facility Name
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
City
Cluj-Napoca
ZIP/Postal Code
400124
Country
Romania
Facility Name
Spitalul Clinic Municipal Filantropia Craiova
City
Craiova
ZIP/Postal Code
200143
Country
Romania
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169856
Country
Singapore
Facility Name
ICO Badalona - Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Ankara University Hospital
City
Altındağ
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Hacettepe University Hospital
City
Altındağ
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Bursa Uludag University Hospital
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Ege University Hospital
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Kayseri Erciyes University Hospital
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
King's College Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
SE5 9NU
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
W120HS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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