Phase I Study of Nimotuzumab in Solid Tumours

February 27, 2007 updated by: YM BioSciences

A Phase I Study of TheraCIM-hR3 (YMB1000) in Patients With Solid Tumours

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

YM BioSciences

Collaborators

CIMYM BioSciences

Investigators

  • Principal Investigator: Eric Chen, MD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Registration Dates

First Submitted

August 25, 2006

First Submitted That Met QC Criteria

August 25, 2006

First Posted (Estimate)

August 29, 2006

Study Record Updates

Last Update Posted (Estimate)

February 28, 2007

Last Update Submitted That Met QC Criteria

February 27, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YMB1000-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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