Phase I Study of Nimotuzumab in Solid Tumours

This study has been completed.
Sponsor:
Collaborator:
CIMYM BioSciences
Information provided by:
YM BioSciences
ClinicalTrials.gov Identifier:
NCT00369252
First received: August 25, 2006
Last updated: February 27, 2007
Last verified: February 2007
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of TheraCIM-hR3 (YMB1000) in Patients With Solid Tumours

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00369252     History of Changes
Other Study ID Numbers: YMB1000-007
Study First Received: August 25, 2006
Last Updated: February 27, 2007
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 16, 2014