Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

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

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)

Details

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.

Keywords

Healthy (For Part A) Chronic Myeloid Leukemia (for Part B and C) CML Chronic Myelogenous Leukemia K0706 Vodobatinib ponatinib-refractory/intolerant treatment refractory chronic myeloid leukemia Ponatinib Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Vodobatinib (K0706) capsules

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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).

You CAN'T join if...

  • 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

Locations

  • UCLA Hematologic Malignancy Program not yet accepting patients
    Los Angeles California 90024 United States
  • University of Southern California accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sun Pharma Advanced Research Company Limited
ID
NCT02629692
Phase
Phase 1/2
Study Type
Interventional
Last Updated