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Phase I Study of Nimotuzumab in Solid Tumours

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00369252
First Posted: August 29, 2006
Last Update Posted: February 28, 2007
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.
Collaborator:
CIMYM BioSciences
Information provided by:
YM BioSciences
  Purpose
This is a phase I trial of nimotuzumab that will be conducted in patients with advanced incurable solid tumors. This is a dose-seeking study to determine the maximum tolerated and recommended phase II doses of nimotuzumab that can be safely given to patients with advanced and/or metastatic solid tumors.

Condition Intervention Phase
Advanced and/or Metastatic Solid Tumours Drug: Nimotuzumab (TheraCIM h-R3) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of TheraCIM-hR3 (YMB1000) in Patients With Solid Tumours

Further study details as provided by YM BioSciences:

Estimated Enrollment: 18
Study Start Date: June 2005
Detailed Description:
This is an open-label, dose-escalating, phase I trial of nimotuzumab in patients with advanced incurable solid tumors. The objective of this study is to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of nimotuzumab that can be given in a weekly schedule in patients with advanced and/or metastatic solid tumor cancer. This study will also examine the safety, pharmacodynamics and preliminary efficacy of nimotuzumab in this patient population.
  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:

  • Advanced and/or metastatic solid tumors, refractory to standard curative therapy, or for which no curative therapy exists.
  • Clinically or radiologically documented disease. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan.
  • Archival tumor specimens evaluable for expression of the EGFR (but EGFR positivity is not a requirement for study entry).
  • Patients must have tumor lesions accessible for biopsy for correlative studies. In cases where there are medical contraindications to tumor biopsies, exceptions may be made upon discussion with the Principal Investigators.
  • Age > 18 years.
  • ECOG performance status of 0,1,2.
  • Previous therapy: Previous chemotherapy, hormonal therapy, radiation and/or surgery is permitted with certain restrictions as outlined in the protocol.
  • Hematology and chemistry lab results within specifications outlined in the protocol.
  • Willingness to give written informed consent.
  • Patients must be accessible for treatment and follow-up.
  • Protocol treatment is to begin within 2 working days of patient registration.

Exclusion Criteria:

  • Pregnant or lactating women. Both men and women enrolled on study should be using adequate birth control measures throughout the course of the study.
  • History of second malignancy who have a disease-free interval of less than two years (except cervical cancer in situ or nonmelanomatous skin cancer).
  • Untreated brain or meningeal metastases. Patients with treated and stable brain metastases are eligible providing that they have radiologic evidence of disease stabilisation of at least 3 months duration and are asymptomatic.
  • Untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction.
  • Active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
  • Prior therapy with EGFR targeting therapies, including monoclonal antibodies or small molecule tyrosine kinase inhibitors.
  • Allergy to the antibody.
  • Concurrent treatment with other experimental drugs or anti-cancer therapy.
  • Inability or unwillingness to give written, informed consent prior to study participation.
  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): NCT00369252


Locations
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
YM BioSciences
CIMYM BioSciences
Investigators
Principal Investigator: Eric Chen, MD University Health Network, Toronto
Principal Investigator: Lillian Siu, MD University Health Network, Toronto
  More Information

ClinicalTrials.gov Identifier: NCT00369252     History of Changes
Other Study ID Numbers: YMB1000-007
First Submitted: August 25, 2006
First Posted: August 29, 2006
Last Update Posted: February 28, 2007
Last Verified: February 2007

Keywords provided by YM BioSciences:
Nimotuzumab
TheraCIM
H-R3
Solid tumours
EGFR
Monoclonal antibody