A Phase I/II Study of K0706 in Recurrent or Persistent Chronic Myelogenous Leukemia and Acute Lymphoblastic Leukemia

Full 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)

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug K0706 in patients with chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that has continued to grow or came back despite treatment with available standard therapies (drugs called TKI inhibitors).

Leukemia, including CML and Ph+ ALL, is a cancer of the blood in which the body makes too many white blood cells. K0706 slows or stops the action of the BCR-ABL tyrosine kinase protein. This protein is central to the growth of leukemias like CML and Ph+ ALL. Inhibiting this protein has been shown to slow or stop some leukemia cell growth and allow healthy blood cells to return.

K0706 was designed to overcome the resistance that can develop to other medicines, while also being associated with fewer side effects. Researchers in this study want to find the highest dose of K0706 that can be given safely in patients. K0706 is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have CML or Ph+ ALL that came back or has continued to grow despite prior tyrosine kinase inhibitors (such as imatinib, dasatinib, nilotinib, bosutinib, and ponatinib).
  • Patients must recover from the serious side effects of prior therapies before entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Michael Mauro at 212-639-3107.

Protocol

18-229

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators