CetuGEX: dose escalation study (clinicaltrials.gov) - Apr 26, 2012 - P1, N=85; Recruiting; Completion date: Mar 2012 -> Jun 2012
Completion date • Oncology
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This study is currently recruiting participants
Verified April 2012 by Glycotope GmbH
First Received on October 15, 2010. Last Updated on April 26, 2012 History of Changes
Sponsor: Glycotope GmbH
Collaborator: Glycotope Biotechnology GmbH
Information provided by: Glycotope GmbH
ClinicalTrials.gov Identifier: NCT01222637
Purpose
This is a prospective, open label, multicenter study evaluating the safety, tolerability and pharmacokinetics of CetuGEX™ after intravenous administration in patients with EGFR positive, locally advanced and/or metastatic solid cancers. The effect of CetuGEX™ on the development of anti-drug antibodies and on tumour response will also be evaluated.
Condition
Solid Tumors
Intervention
Drug: CetuGEX™
Phase
Phase 1
Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose-escalation, PK- and Safety Study With Single Agent CetuGEX™ in Patients With EGFR Positive Locally Advanced and/or Metastatic Cancer
Resource links provided by NLM:
MedlinePlus related topics: Cancer
U.S. FDA Resources
Further study details as provided by Glycotope GmbH:
Primary Outcome Measures:
To evaluate the safety and tolerability profile of CetuGEX™ at various dose levels [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
To define the recommended phase II dose and regimen [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
To determine the pharmacokinetics of CetuGEX™ in patients after single and multiple dose applications [ Designated as safety issue: No ]
To make a preliminary evaluation of anti-tumour activity of CetuGEX™ in the selected patient population(s) [ Designated as safety issue: No ]
Estimated Enrollment: 85
Study Start Date: August 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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