Clinical Trials /

Pharmacological Study of Intravenous OTS167 in Patients With Refractory or Relapsed Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Advanced Myelodysplastic Syndromes, Advanced Myeloproliferative Neoplastic Disorders, or Advanced Chronic Myelogenous Leukemia

NCT02795520

Description:

The purpose of Phase I of this study is to test the safety and tolerability of the investigational drug, OTS167, and that of Phase II of this study is to confirm the potential response benefit of OTS167. OTS167 is a maternal embryonic leucine zipper kinase (MELK) inhibitor which demonstrated antitumor properties in laboratory tests. It is being developed as an anti-cancer drug. In this study OTS167 will be administrated to patients with AML, ALL, advanced MDSs, advanced MPNs, or advanced CML.

Related Conditions:
  • Acute Biphenotypic Leukemia
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Chronic Myeloid Leukemia
  • Myelodysplastic Syndromes
  • Myeloproliferative Neoplasm
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Pharmacological Study of Intravenous OTS167 in Patients With Refractory or Relapsed Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Advanced Myelodysplastic Syndromes, Advanced Myeloproliferative Neoplastic Disorders, or Advanced Chronic Myelogenous Leukemia
  • Official Title: Phase I/II and Pharmacological Study of Intravenous OTS167 in Patients With Refractory or Relapsed Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Advanced Myelodysplastic Syndromes, Advanced Myeloproliferative Neoplastic Disorders, or Advanced Chronic Myelogenous Leukemia

Clinical Trial IDs

  • ORG STUDY ID: OTS167-SE02
  • NCT ID: NCT02795520

Conditions

  • AML
  • Advanced MDS
  • ALL
  • Advanced CML
  • Advanced MPNs

Interventions

DrugSynonymsArms
OTS167IVOTS167IV

Purpose

The purpose of Phase I of this study is to test the safety and tolerability of the investigational drug, OTS167, and that of Phase II of this study is to confirm the potential response benefit of OTS167. OTS167 is a maternal embryonic leucine zipper kinase (MELK) inhibitor which demonstrated antitumor properties in laboratory tests. It is being developed as an anti-cancer drug. In this study OTS167 will be administrated to patients with AML, ALL, advanced MDSs, advanced MPNs, or advanced CML.

Trial Arms

NameTypeDescriptionInterventions
OTS167IVExperimental
  • OTS167IV

Eligibility Criteria

        Inclusion Criteria:

          1. Diagnosis of relapsed or refractory AML, ALL, acute biphenotypic leukemia (assigned
             to the appropriate group by the treating physician and pathology/cytogenetics),
             advanced MDS defined as ≥10% bone marrow blasts, advanced MPN, MDS/MPN overlap
             syndrome with ≥10% bone marrow blasts, or advanced CML after failure of at least 3
             TKIs

          2. Age ≥18 years

          3. No prior antineoplastic drug therapy for at least 14 days, with the exception of
             hydroxyurea, prior to starting OTS167. Patients with rapidly proliferative disease
             may continue to receive hydroxyurea.

          4. Patients with a diagnosis of advanced CML must have been treated with 3 prior TKIs,
             and the last therapy must have been discontinued 14 days prior to starting OTS167.

          5. Adequate organ function as defined below:

               -  Liver function (total bilirubin <2mg/dL and aspartate aminotransferase and/or
                  alanine aminotransferase <3 × upper limit of normal (ULN) or <5 × ULN if related
                  to leukemic involvement)

               -  Renal function (creatinine <1.5 × ULN)

          6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

          7. Negative urine pregnancy test within 1 week prior to Cycle 1 Day 1 for each woman of
             childbearing potential

          8. Able to understand the potential risks, benefits, and requirements of the study and
             are willing to provide informed consent; an informed consent form for this study that
             is signed by the patient or his/her legally authorized representative is required
             prior to enrollment

        Exclusion Criteria:

          1. Diagnosis of relapsed or refractory AML, ALL, acute biphenotypic leukemia (assigned
             to the appropriate group by the treating physician and pathology/cytogenetics),
             advanced MDS defined as ≥10% bone marrow blasts, advanced MPN, MDS/MPN overlap
             syndrome with ≥10% bone marrow blasts, or advanced CML after failure of at least 3
             TKIs

          2. Age ≥18 years

          3. No prior antineoplastic drug therapy for at least 14 days, with the exception of
             hydroxyurea, prior to starting OTS167. Patients with rapidly proliferative disease
             may continue to receive hydroxyurea.

          4. Patients with a diagnosis of advanced CML must have been treated with 3 prior TKIs,
             and the last therapy must have been discontinued 14 days prior to starting OTS167.

          5. Adequate organ function as defined below:

               -  Liver function (total bilirubin <2mg/dL and aspartate aminotransferase and/or
                  alanine aminotransferase <3 × upper limit of normal (ULN) or <5 × ULN if related
                  to leukemic involvement)

               -  Renal function (creatinine <1.5 × ULN)

          6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

          7. Negative urine pregnancy test within 1 week prior to Cycle 1 Day 1 for each woman of
             childbearing potential

          8. Able to understand the potential risks, benefits, and requirements of the study and
             are willing to provide informed consent; an informed consent form for this study that
             is signed by the patient or his/her legally authorized representative is required
             prior to enrollment
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Adverse events assessed by CTCAE v4.03
Time Frame:Up to 30 days after last dose of study drug
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:OncoTherapy Science, Inc.

Last Updated

June 6, 2016