Status:
COMPLETED
TrasGEX™: Phase 1 Study in Cancer Patients
Lead Sponsor:
Glycotope GmbH
Collaborating Sponsors:
Glycotope Biotechnology GmbH
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This was a prospective, open label, multicenter study evaluating the safety, tolerability and pharmacokinetics of TrasGEX™ after intravenous administration in patients with HER-2 positive cancers. The...
Detailed Description
Adult patients with advanced and/or metastatic HER2-positive cancer who were resistant to or for whom there was no standard anti-tumor therapy available at the time of enrollment and who had an estima...
Eligibility Criteria
Inclusion
- Main
- Signed written informed consent granted prior to initiation of any study-specific procedures;
- Male or female patients of ≥18 years of age;
- ERBB2 (HER-2) gene amplification or ERBB2 overexpression
- Histologically or cytologically confirmed cancer, either locally advanced or metastatic;
- No anti-tumor therapy of proven benefit available at study enrollment;
- Life expectancy of \>=3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<=2;
- Male or female patients of child-producing potential must agree to use contraceptive measures or oral contraception during the study and for 28 days after the last dose of TrasGEX™;
- Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of TrasGEX™;
- and
- Main
Exclusion
- Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks of the first dose of TrasGEX™;
- Major surgery within four weeks of the first dose of TrasGEX™;
- Newly diagnosed brain metastases, metastases that have been documented to be stable for \<3 months, or metastases for which systemic corticosteroids are required;
- History of allergic reactions attributed to compounds of similar chemical or biologic composition as TrasGEX™;
- History of myocardial infarction within 12 months of the administration of the first dose of TrasGEX™;
- History of congestive heart failure defined as Class II to IV per New York Heart Association classification within 12 months of the administration of the first dose of TrasGEX™;
- Left ventricular ejection fraction \<50%;
- Previous malignancy other than the current diagnosis within 5 years of the first dose of TrasGEX™;
- Pregnancy or lactation; and
- Concurrent uncontrolled significant illness
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01409343
Start Date
July 1 2011
End Date
December 1 2013
Last Update
May 7 2021
Active Locations (5)
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1
Glycotope Investigational Site
Graz, Austria, 8036
2
Glycotope Investigational Site
Innsbruck, Austria, 6020
3
Glycotope Investigational Site
Hamburg, Germany, 20246
4
Glycotope Investigational Site
Milan, Italy