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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

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ClinicalTrials.gov Identifier: NCT02795520
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
OncoTherapy Science, Inc.

May 6, 2016
June 10, 2016
September 26, 2018
April 2016
December 2019   (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
Same as current
December 2019
December 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
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 2018

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