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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01281592
First Posted: January 24, 2011
Last Update Posted: February 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aptose Biosciences Inc.
  Purpose
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.

Condition Intervention Phase
Advanced or Metastatic Solid Tumours Drug: LOR-253 HCl Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Phase 1 Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours

Further study details as provided by Aptose Biosciences Inc.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • To characterize the safety profile of LOR-253 HCl when administered to patients with advanced or metastatic solid tumours. [ Time Frame: 8 weeks ]

Enrollment: 36
Study Start Date: January 2011
Study Completion Date: January 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Name: No other names are used.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01281592


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Aptose Biosciences Inc.
Investigators
Principal Investigator: Andrea Cercek, M.D. Memorial Sloan Kettering Cancer Center
Principal Investigator: Jennifer Wheler, MD M.D. Anderson Cancer Center
  More Information

Responsible Party: Aptose Biosciences Inc.
ClinicalTrials.gov Identifier: NCT01281592     History of Changes
Other Study ID Numbers: 253-SOL1-01
First Submitted: January 20, 2011
First Posted: January 24, 2011
Last Update Posted: February 25, 2014
Last Verified: February 2014