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

This study is currently recruiting participants.
Verified February 2013 by Lorus Therapeutics
Sponsor:
Information provided by (Responsible Party):
Lorus Therapeutics
ClinicalTrials.gov Identifier:
NCT01281592
First received: January 20, 2011
Last updated: February 5, 2013
Last verified: February 2013
History of Changes

January 20, 2011
February 5, 2013
January 2011
June 2013   (final data collection date for primary outcome measure)
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 ]
To determine the maximum tolerated dose and 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 ]
Complete list of historical versions of study NCT01281592 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Study of LOR-253 HCl in Patients With Advanced or Metastatic Solid Tumours
Open-Label, Phase 1 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.
Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced or Metastatic Solid Tumours
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.
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.
Intervention: Drug: LOR-253 HCl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
37
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Shawn Zhou szhou@lorusthera.com
Contact: Peter Murray pmurray@lorusthera.com
United States
 
NCT01281592
253-SOL1-01
Not Provided
Lorus Therapeutics
Lorus Therapeutics
Not Provided
Principal Investigator: Andrea Cercek, M.D. Memorial Sloan-Kettering Cancer Center
Principal Investigator: Jennifer Wheler, MD M.D. Anderson Cancer Center
Lorus Therapeutics
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP