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

Phase 1

Completed

• Conditions: Advanced or Metastatic Solid Tumours
• Interventions: Drug: LOR-253 HCl

• Registration Number: NCT01281592
• Lead Sponsor: Aptose Biosciences Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-01-20
• Study First Posted: 2011-01-24
• Primary Completion: 2013-07
• Study Completion: 2014-01
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-21
• Last Update Posted: 2014-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LOR-253 HCl	LOR-253 HCl	LOR-253 HCl will be given in ascending doses until the maximum administered dose or appropriate target dose is reached. A biomarker study of up to 10 patients will be conducted upon achieving appropriate dose level.

Primary Outcome Measures

Name	Time	Method
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.	8 weeks

Secondary Outcome Measures

Name	Time	Method
To characterize the safety profile of LOR-253 HCl when administered to patients with advanced or metastatic solid tumours.	8 weeks

Trial Locations

Locations (2)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States