A Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours

Aptose Biosciences Inc.36 enrolled

Overview

This is an open-label, phase 1 study to determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced or Metastatic Solid Tumours

Interventions

LOR-253 HClDRUG

LOR-253 HCl will be given in ascending doses starting from 20 mg/m2 until the maximum administered dose or appropriate target dose is reached. Patient will be treated on LOR-253 HCl for 2 cycles for the evaluation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female 18 years of age or older. 2. Histologically confirmed diagnosis of solid tumour for which no effective therapy is available or that is unresponsive to conventional therapy. 3. Meet laboratory parameter requirements at study entry. Exclusion Criteria: 1. Chemotherapy, radiotherapy, biologic therapy, immunotherapy or any other investigational drugs within 21 days of beginning study treatment with LOR-253 HCl. 2. A hematologic malignancy. 3. A history of brain or other central nervous system metastases. 4. Have a presence of a significant infection. 5. Clinically significant autoimmune disease. 6. Uncontrolled intercurrent illness. 7. With iron or copper overload syndromes. 8. Pregnancy or breast feeding.

Locations (2)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

To determine the maximum tolerated dose (MTD) or appropriate target dose if MTD not reached to identify the recommended phase 2 dose of LOR-253 HCl in patients with advanced or metastatic solid tumours.

Time frame: 8 weeks

Secondary Outcomes

To characterize the safety profile of LOR-253 HCl when administered to patients with advanced or metastatic solid tumours.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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