Phase 1 Study of OTS167 in Patients With Solid Tumors

Completed · Phase 1

Conditions studied: Solid Tumors, Metastatic Tumors

In brief

The purpose of this study is to test the safety and tolerability of an investigational drug called 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 first-in-human study OTS167 will be administered to patients with solid tumors which have not responded to treatment.

Key facts

Study ID: NCT01910545
Run by: OncoTherapy Science, Inc.
People needed: 32
Starts: 2013-08-23
Expected to finish: 2016-05-04
Last updated by the study team: 2017-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female patients, >= 18 years of age at the time of obtaining informed consent.
Patients with a documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic.
Patients with a malignancy that is either refractory to standard therapy or for which no standard therapy is available.
Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.
Patients with measurable or non-measurable disease according to the response evaluation criteria in solid tumors (RECIST , v1.1)
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Patients, both male and female, who are either not of childbearing potential or who agree to use a medically effective method of contraception during the study and for 3 months after the last dose of study drug.
Patients with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.

You may not qualify if…

Women who are pregnant or lactating. Women of child-bearing potential (WOCBP), and fertile men with a WOCBP-partner not using adequate birth control.
Patients with known central nervous system (CNS) or leptomeningeal metastases not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required.
Patients with any hematologic malignancy. This includes leukemia (any form), lymphoma, and multiple myeloma.
Patients with any of the following hematologic abnormalities at baseline:
Absolute neutrophil count (ANC) < 1,500 per mm3
Platelet count < 100,000 per mm3
Patients with any of the following serum chemistry abnormalities at baseline:
Total bilirubin >= 1.5 × the ULN for the institution
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= 3 × the upper limit normal (ULN) for the institution (>= 5 × if due to hepatic involvement by tumor)
Serum albumin < 2.5 g/dL
Creatinine >= 1.5 × ULN for the institution (or a calculated creatinine clearance < 60 mL/min/1.73 m2)
Patients with a significant cardiovascular disease or condition, including:
Congestive heart failure (CHF) currently requiring therapy
Need for antiarrhythmic medical therapy for a ventricular arrhythmia
Severe conduction disturbance
Angina pectoris requiring therapy
Corrected QT (QTc) interval > 450 msec (males) or > 470 msec (females)
QTc interval <= 300 msec
History of congenital long QT syndrome or congenital short QT syndrome
Left ventricular ejection fraction < 50%
Uncontrolled hypertension (per the Investigator's discretion)
Class III or IV cardiovascular disease according to the New York Heart Association's (NYHA) Functional Criteria.
Myocardial infarction (MI) within 6 months prior to first study drug administration
Patients with a known or suspected hypersensitivity to any of the components of OTS167.
Patients with a known history of human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).

Where it is running

University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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