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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

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.
 
ClinicalTrials.gov Identifier: NCT02795520
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
OncoTherapy Science, Inc.

Tracking Information
First Submitted Date  ICMJE May 6, 2016
First Posted Date  ICMJE June 10, 2016
Last Update Posted Date April 8, 2020
Actual Study Start Date  ICMJE April 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
Adverse events assessed by CTCAE v4.03 [ Time Frame: Up to 30 days after last dose of study drug ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • AML
  • Advanced MDS
  • ALL
  • Advanced CML
  • Advanced MPNs
Intervention  ICMJE Drug: OTS167IV
Study Arms  ICMJE Experimental: OTS167IV
Intervention: Drug: OTS167IV
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnosis of:

    • Relapsed or refractory AML (refractory to a standard anthracycline-based induction regimen or a hypomethylating agent for patients unfit for intensive chemotherapy or for whom no standard or curative therapy exists),
    • ALL,
    • Acute biphenotypic leukemia (assigned to the appropriate group by the treating physician by documented analysis of relevant laboratory values and pathology/cytogenetics),
    • Advanced MDS defined as ≥5% bone marrow blasts or ≥2% blasts in the peripheral blood (including patients who have progressed following treatment with hypomethylating agents),
    • Advanced MPN (excluding patients with ET, PV, or low risk MF), and MDS/MPN overlap syndrome with ≥5% bone marrow blasts or ≥2% blasts in the peripheral blood, or
    • Advanced CML after failure/progression of at least 3 prior 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 refractory to all approved therapies or for which no approved or conventional therapies are available
  5. Patients with a diagnosis of advanced CML must have been treated with 3 prior TKIs, and the last therapy must have been discontinued at least 14 days prior to starting OTS167
  6. Adequate organ function as defined below:

    • Liver function (total bilirubin <2 mg/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)
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  8. Negative urine pregnancy test within 1 week prior to Cycle 1 Day 1 for each woman of childbearing potential
  9. Able to understand the potential risks, benefits, and requirements of the study and are willing to provide informed consent; an informed consent form (ICF) for this study that is signed by the patient or his/her legally authorized representative is required prior to enrollment

Exclusion Criteria:

  1. Pregnant or breastfeeding patients (pregnant and breastfeeding women are excluded from this study because the agents used in this study may have unknown or unrecognized potential for teratogenic or abortifacient effects). Patients of childbearing potential must consent and agree to practice documented (type) adequate contraception during the course of on study treatment.
  2. Evidence of any form of active, uncontrolled, bacterial, viral (including hepatitis A, B, or C or known human immunodeficiency virus [HIV] seropositivity), or fungal infection. Patients who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR-positive will be excluded. Evidence of congestive heart failure (New York Heart Association Class III or IV); myocardial infarction or stroke within 6 months; unstable angina; uncontrolled or unstable/medically important cardiac arrhythmia; prolonged QT interval corrected for heart rate (QTc) >450 msec (males) or >470 msec (females); uncontrolled epilepsy; uncontrolled bleeding; recent major surgical procedures within 30 days before Cycle 1 Day 1 without full recovery from the same; or any other serious comorbid medical condition that would preclude investigational study treatment
  3. Any psychiatric illness/social situations that would limit compliance with study requirements
  4. Documented hypersensitivity to any of the components of OTS167 or supportive care medicaments
  5. Central nervous system (CNS) leukemia
  6. MPN patients with ET, PV, or low risk MF
  7. Women of childbearing potential and men must agree prior to study entry to use appropriate contraception for the duration of study participation and until 30 days after receipt of the last dose of study drug
  8. Documented concurrent malignancy. Exceptions include cervical carcinoma in-situ, non-melanoma skin cancer (basal and squamous cell carcinoma), localized prostate cancer (Gleason score <6), and resected melanoma-in-situ. Other localized solid tumors in situ and other low risk cancers may also be exempt after discussion with the Sponsor Medical Monitor.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02795520
Other Study ID Numbers  ICMJE OTS167-SE02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party OncoTherapy Science, Inc.
Study Sponsor  ICMJE OncoTherapy Science, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Olatoyosi Odenike, MBBS University of Chicago, Ilinois
PRS Account OncoTherapy Science, Inc.
Verification Date April 2020

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