Status:
COMPLETED
CetuGEX™: Phase 1 Study in Cancer Patients
Lead Sponsor:
Glycotope 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 CetuGEX™ after intravenous administration in patients with EGFR positive, locally adva...
Detailed Description
Male or female patients ≥18 years of age with a histologically confirmed locally advanced and/or metastatic solid organ tumor. Patients enrolled in Germany were required to have a positive EGFR overex...
Eligibility Criteria
Inclusion
- Male or female and age ≥ 18 yrs
- Histologically confirmed EGFR positive locally advanced and/or metastatic solid organ tumour
- Measurable or non-measurable tumour
- Failure of standard therapy or non-availability of standard therapy (Patients must have received at least 1 line of chemotherapy and further standard therapy is not an option at study entry)
- All anti-tumour therapies must be completed 4 weeks before start of study treatment; treatment with Cetuximab must be completed at least 6 weeks prior to study start
- ECOG Performance Status ≤1 and estimated life expectancy of ≥ 3 months
- Adequate organ function:
- Bone marrow function: hemoglobin ≥ 100 g/L; white blood cell count (WBC) ≥ 3.0 x 10\^9/L; absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L; platelet count ≥ 100 x 10\^9/L
- Hepatic: aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤ 2.5 times upper limit of normal (ULN) (≤ 5 x ULN if hepatic metastases present); bilirubin ≤ 1.5 x ULN; alkaline phosphatase ≤ 5.0 x upper limit of normal (ULN)
- Renal: creatinine \< 1.5 x ULN
- Patients of both genders with procreative potential must use effective contraception while enrolled in the study and for at least 4 weeks after the last study drug infusion
- Written informed consent must be obtained prior to conducting any study-specific procedures
- For Expansion Phase only:
- No prior treatment with Cetuximab allowed
Exclusion
- Chemotherapy, radiation, other anti-cancer therapies including any investigational agents at the study enrolment within 4 weeks prior to study enrolment
- Concurrent anti-tumour therapy or concurrent immunotherapy
- Concurrent systemic steroids except topical (inhaled, topical, nasal) or replacement therapy for the last 28 days.
- Major surgery within 4 weeks prior entering the study and/or incomplete recovery from surgery or planned major surgery
- Primary or secondary immune deficiency
- Clinically active infections \> CTCAE grade 2
- Prior allergic reaction to a monoclonal antibody (e.g. Trastuzumab, Cetuximab or Bevacizumab).
- Active hepatitis B assessed by serology, hepatitis C by histology; human immunodeficiency virus (HIV) seropositivity
- Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix. Patients with a previous malignancy but without evidence of disease for ≥ 3 years will be allowed to enter the study.
- Uncontrolled medical condition considered as high risk for the treatment with an investigational drug including unstable diabetes mellitus, vena-cava-syndrome, chronic symptomatic respiratory disease.
- Clinical signs of brain metastasis or leptomeningeal involvement
- Symptomatic congestive heart failure (New York Heart Association \[NYHA\] 3 or 4); unstable angina pectoris within 6 months prior to enrollment; significant cardiac arrhythmia, or history of stroke or transient ischemic attack within 1 year.
- Active drug abuse or chronic alcoholism
- Pregnancy or Breastfeeding
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01222637
Start Date
August 1 2010
End Date
October 1 2013
Last Update
May 25 2021
Active Locations (5)
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1
Glycotope Investigational Site
Hamburg, Germany, D-20246
2
Glycotope Investigational Site
Heidelberg, Germany, D-69120
3
Glycotope Investigational Site
Milan, Italy, 20132
4
Glycotope Investigational Site
Milan, Italy, 20133