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Completed

NCT Number: NCT01281592

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

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.

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Key information

Conditions

Advanced or Metastatic Solid Tumours

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan-Kettering Cancer Center, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female 18 years of age or older.
  • Histologically confirmed diagnosis of solid tumour for which no effective therapy is available or that is unresponsive to conventional therapy.
  • Meet laboratory parameter requirements at study entry.

Exclusion criteria

  • Chemotherapy, radiotherapy, biologic therapy, immunotherapy or any other investigational drugs within 21 days of beginning study treatment with LOR-253 HCl.
  • A hematologic malignancy.
  • A history of brain or other central nervous system metastases.
  • Have a presence of a significant infection.
  • Clinically significant autoimmune disease.
  • Uncontrolled intercurrent illness.
  • With iron or copper overload syndromes.
  • Pregnancy or breast feeding.

Treatment and study plan

LOR-253 HCl

Drug

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 names: No other names are used.

Primary outcomes

  1. 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

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

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Aptose Biosciences Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jan 24, 2011
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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