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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lorus Therapeutics
ClinicalTrials.gov Identifier:
NCT01281592
First received: January 20, 2011
Last updated: February 21, 2014
Last verified: February 2014
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Phase 1 Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours

Resource links provided by NLM:


Further study details as provided by Lorus Therapeutics:

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Lorus Therapeutics
Investigators
Principal Investigator: Andrea Cercek, M.D. Memorial Sloan-Kettering Cancer Center
Principal Investigator: Jennifer Wheler, MD M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: Lorus Therapeutics
ClinicalTrials.gov Identifier: NCT01281592     History of Changes
Other Study ID Numbers: 253-SOL1-01
Study First Received: January 20, 2011
Last Updated: February 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014