Clinical Trials /

Safety, Tolerability, Pharmacokinetics and Activity of K0706

NCT02629692

Description:

Phase 1/2 study to determine safety, tolerability, pharmacokinetics and activity of K0706

Related Conditions:
  • Acute Lymphoblastic Leukemia
  • Chronic Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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)

Clinical Trial IDs

  • ORG STUDY ID: CLR_15_03 V 10 amendment 10
  • NCT ID: NCT02629692

Conditions

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

Interventions

DrugSynonymsArms
K0706K0706
PlaceboPlacebo

Purpose

Phase 1/2 study to determine safety, tolerability, pharmacokinetics and activity of K0706

Detailed Description

      Part A ( for Healthy volunteers) of the study is completed Part B (for CML subject ) of the
      study is ongoing. (Recruitment for Part B initiated in April 2017) Part C of study in
      subjects with CML and Ph+ ALL is on-going. (Open for Recruitment )
    

Trial Arms

NameTypeDescriptionInterventions
K0706ExperimentalPart B: Single arm,open-label,dose escalation - Ongoing (Initiated enrollment in April 2017) Part C: Open label (study is on-going, open for recruitment)
  • K0706
PlaceboPlacebo ComparatorPart A of the study: Two arm,Placebo-Controlled,double blind - Completed on Nov 2016
  • K0706
  • Placebo

Eligibility Criteria

        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, or Ph+ ALL

        Exclusion Criteria:

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Part B: Maximum tolerated dose
Time Frame:Dose limiting toxicity is to be observed during 4 week period
Safety Issue:
Description:The proportion of subjects who achieve complete cytogenetic response (No Ph+ cells), or partial cytogenetic response (1-35% Ph+ cells) after the initiation of study treatment

Secondary Outcome Measures

Measure:Part B and C: Tmax
Time Frame:24 hours post dose
Safety Issue:
Description:
Measure:Part B and C: Maximum plasma concentration
Time Frame:24 hours post dose
Safety Issue:
Description:
Measure:Part B and C: Area under the plasma concentration time curve (0-24 hours)
Time Frame:24 hours post dose
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sun Pharma Advanced Research Company Limited

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