Active Not Recruiting PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT02629692

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

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)

Sponsor: Sun Pharma Advanced Research Company Limited

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

Interventions Vodobatinib (K0706) capsules

Updated 25 times since 2017 Last updated: Jul 30, 2024 Started: Jun 27, 2016 Primary completion: Aug 31, 2026 Completion: Aug 31, 2026

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Chronic Myeloid Leukemia (for Part B and C) and Healthy (For Part A) and is currently ongoing. Sun Pharma Advanced Research Company Limited leads this study, which shows 25 recorded versions since 2016 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

25 versions recorded

Sep 2025 — Present [monthly]

Active Not Recruiting PHASE1/PHASE2
Sep 2024 — Sep 2025 [monthly]

Active Not Recruiting PHASE1/PHASE2
Aug 2024 — Sep 2024 [monthly]

Active Not Recruiting PHASE1/PHASE2
Jul 2024 — Aug 2024 [monthly]

Active Not Recruiting PHASE1/PHASE2

Phase: PHASE1_PHASE2 → PHASE1/PHASE2
Nov 2023 — Jul 2024 [monthly]

Active Not Recruiting PHASE1_PHASE2

▶ Show 20 earlier versions

Aug 2023 — Nov 2023 [monthly]

Active Not Recruiting PHASE1_PHASE2

Status: Recruiting → Active Not Recruiting
Jul 2023 — Aug 2023 [monthly]

Recruiting PHASE1_PHASE2
Jun 2023 — Jul 2023 [monthly]

Recruiting PHASE1_PHASE2
Jan 2023 — Jun 2023 [monthly]

Recruiting PHASE1_PHASE2
May 2022 — Jan 2023 [monthly]

Recruiting PHASE1_PHASE2
Mar 2021 — May 2022 [monthly]

Recruiting PHASE1_PHASE2
Jan 2021 — Mar 2021 [monthly]

Recruiting PHASE1_PHASE2
Dec 2020 — Jan 2021 [monthly]

Recruiting PHASE1_PHASE2
Jul 2020 — Dec 2020 [monthly]

Recruiting PHASE1_PHASE2
Jun 2020 — Jul 2020 [monthly]

Recruiting PHASE1_PHASE2
Jul 2019 — Jun 2020 [monthly]

Recruiting PHASE1_PHASE2
Jun 2019 — Jul 2019 [monthly]

Recruiting PHASE1_PHASE2
Apr 2019 — Jun 2019 [monthly]

Recruiting PHASE1_PHASE2
Dec 2018 — Apr 2019 [monthly]

Recruiting PHASE1_PHASE2
Nov 2018 — Dec 2018 [monthly]

Recruiting PHASE1_PHASE2
Jul 2018 — Nov 2018 [monthly]

Recruiting PHASE1_PHASE2
Jun 2018 — Jul 2018 [monthly]

Recruiting PHASE1_PHASE2
Mar 2018 — Jun 2018 [monthly]

Recruiting PHASE1_PHASE2
Feb 2017 — Mar 2018 [monthly]

Recruiting PHASE1_PHASE2
Jan 2017 — Feb 2017 [monthly]

Recruiting PHASE1_PHASE2

First recorded

Jun 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Sun Pharma Advanced Research Company Limited

Data source: Sun Pharma Advanced Research Company Limited

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Altındağ, Turkey (Türkiye) , Augusta, United States , Badalona, Spain , Barcelona, Spain , Brussels, Belgium , Bucharest, Romania , Cluj-Napoca, Romania , Craiova, Romania , Dallas, United States , Debrecen, Hungary and 22 more locations