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

Advanced or Metastatic Solid Tumours Clinical Trial

Official title:

Open-Label, Phase 1 Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01281592
• Other study ID #: 253-SOL1-01
• Status: Completed
• Phase: Phase 1
• First received: January 20, 2011
• Last updated: February 21, 2014
• Start date: January 2011
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: Aptose Biosciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced or Metastatic Solid Tumours

Intervention

Drug:
• LOR-253 HCl
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.

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Aptose Biosciences Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To characterize the safety profile of LOR-253 HCl when administered to patients with advanced or metastatic solid tumours.		8 weeks	Yes