Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment Refractory/Intolerant CML Failing ≥3 Prior CML Therapies
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ClinicalTrials.gov Identifier: NCT02629692 |
Recruitment Status :
Recruiting
First Posted : December 14, 2015
Last Update Posted : April 28, 2022
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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 |
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. |
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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

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

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

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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
CML Chronic Myelogenous Leukemia K0706 Vodobatinib |
ponatinib-refractory/intolerant treatment refractory chronic myeloid leukemia Ponatinib |
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type |
Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |