first in man study with CetuGEX in patients with metastatic cancer

• Conditions: Histologically confirmed locally advanced and/or metastatic solid organ tumour; MedDRA version: 14.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-019552-50-DE
• Lead Sponsor: Glycotope GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-19
• Last Update Posted: 19 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

1.1.Male or female and age =18 yrs
2.Histologically confirmed locally advanced and/or metastatic solid organ tumour
3.Measurable or non-measurable tumour
4.Not eligible for standard therapy
5.All anti-tumor 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
6.ECOG Performance Status =1 and estimated life expectancy of = 3 months

7.Adequate organ function:
•Bone marrow function: hemoglobin = 100 g/L; white blood cell count (WBC) = 3.0 x 109/L; absolute neutrophil count (ANC) = 1.5 x 109/L; platelet count = 100 x 109/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 xULN
8.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
9.Written informed consent must be obtained prior to conducting any study-specific procedures

For Expansion Phase only:
10. EGFR-positive patients
11. No prior treatment with Cetuximab allowed

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

1.Chemotherapy, radiation, other anti-cancer therapies including any investigational agents at the study enrolment within 4 weeks prior to study enrolment
2.Concurrent anti-tumour therapy or concurrent immunotherapy
3.Concurrent systemic steroids except topical (inhaled, topical, nasal) or replacement therapy for the last 28 days. Steroids at low and stable dose (up to 20 mg prednisone) given for chronic disease are also permitted
4.Major surgery within 4 weeks prior entering the study and/or incomplete recovery from surgery or planned major surgery
5.Primary or secondary immune deficiency
6.Clinically active infections > CTCAE grade 2
7.Prior allergic reaction to a monoclonal antibody (e.g. Trastuzumab, Cetuximab or Bevazicumab)
8.Active hepatitis B assessed by serology, hepatitis C by histology; human immunodeficiency virus (HIV) seropositivity
9.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
10.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
11.Clinical signs of brain metastasis or leptomeningeal involvement
12.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
13.Active drug abuse or chronic alcoholism
14.Pregnancy or Breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary: <br>•To evaluate the safety and tolerability profile of CetuGEXTM at various dose levels <br>•To define the recommended phase II dose and regimen<br>;Secondary Objective: Secondary: <br>•To determine the pharmacokinetics of CetuGEXTM in patients after single and multiple dose applications <br>•To make a preliminary evaluation of anti-tumour activity of CetuGEXTM in the selected patient population (s)<br>;Primary end point(s): •To evaluate the safety and tolerability profile of CetuGEXTM at various dose levels <br>•To define the recommended phase II dose and regimen<br>;Timepoint(s) of evaluation of this end point: Response will be evaluated every 8 weeks. Non-measurable disease allowed for inclusion.<br><br>The events will be followed until resolved, or until the study end, whichever comes later.<br>•Laboratory abnormalities will be recorded throughout the study. <br><br>