Phase 1 Study of OTS167 in Patients With Solid Tumors

NCT01910545 | Completed Phase 1

• 1 other identifier: OTS167-FR02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumors; Metastatic Tumors

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events and/or dose-limiting toxicities as a measure of safety and tolerability of OTS167 IV infusion.

  Up to 30 days after last dose of study drug

Study Arms (1)

OTS167IV

EXPERIMENTAL

single arm

Drug: OTS167IV

Interventions

OTS167IV DRUG

OTS167IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• OncoTherapy Science, Inc.: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: July 29, 2013
• Study Start: August 23, 2013
• Primary Completion: April 11, 2016
• Study Completion: May 4, 2016
• Last Updated: June 1, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)