PhaseI, Single-Center, Cohort Dose Escalation Trial to Determine the Safety, Tolerance, and Preliminary Antineoplastic Activity of OTS167, a MELK Inhibitor, in Patients With Refractory Locally Advanced or Metastatic Solid Tumor Malignancies

OncoTherapy Science, Inc.1 site in 1 country32 target enrollmentAugust 23, 2013

ConditionsSolid Tumors Metastatic Tumors

InterventionsOTS167IV

DrugsOTS167IV

Overview

Phase: Phase 1
Intervention: OTS167IV
Conditions: Solid Tumors
Sponsor: OncoTherapy Science, Inc.
Enrollment: 32
Locations: 1
Primary Endpoint: Number of patients with adverse events and/or dose-limiting toxicities as a measure of safety and tolerability of OTS167 IV infusion.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 23, 2013

End Date

May 4, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

OncoTherapy Science, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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.

Exclusion Criteria

•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