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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

This study is currently recruiting participants.
Verified September 2017 by OncoTherapy Science, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02795520
First Posted: June 10, 2016
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
OncoTherapy Science, Inc.
May 6, 2016
June 10, 2016
September 14, 2017
April 2016
May 2018   (Final data collection date for primary outcome measure)
Adverse events assessed by CTCAE v4.03 [ Time Frame: Up to 30 days after last dose of study drug ]
Same as current
Complete list of historical versions of study NCT02795520 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • AML
  • Advanced MDS
  • ALL
  • Advanced CML
  • Advanced MPNs
Drug: OTS167IV
Experimental: OTS167IV
Intervention: Drug: OTS167IV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
May 2018
May 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
United States
 
 
NCT02795520
OTS167-SE02
No
Not Provided
Not Provided
OncoTherapy Science, Inc.
OncoTherapy Science, Inc.
Not Provided
Principal Investigator: Olatoyosi Odenike, MBBS University of Chicago, Ilinois
OncoTherapy Science, Inc.
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP