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 activity of K0706

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 (for CML subject ) of the study is ongoing only in India, other countries completed. (Recruitment for Part B initiated in April 2017) Part C of study in subjects with CML is on-going in all mentioned countries except India. (Open for Recruitment )

Keywords

Chronic Myeloid Leukemia (for Part B and C) Healthy (For Part A) Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive 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

You CAN'T join if...

  • 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

Locations

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