CetuGEX™: Dose Escalation Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Glycotope GmbH
ClinicalTrials.gov Identifier:
NCT01222637
First received: October 15, 2010
Last updated: December 16, 2013
Last verified: December 2013
  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 Intervention Phase
Solid Tumors
Drug: CetuGEX™
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:


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 [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To make a preliminary evaluation of anti-tumour activity of CetuGEX™ in the selected patient population(s) [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To make a preliminary evaluation of anti-tumour activity of CetuGEX™ in the selected patient püopulation(s) [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: August 2010
Study Completion Date: October 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CetuGEX™, 3-weekly
application q3w
Drug: CetuGEX™
Experimental: CetuGEX™ 2-weekly
application q2w
Drug: CetuGEX™

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female and age ≥ 18 yrs
  2. Histologically confirmed EGFR positive locally advanced and/or metastatic solid organ tumour
  3. Measurable or non-measurable tumour
  4. 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)
  5. 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
  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 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
  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. No prior treatment with Cetuximab allowed

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.
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01222637

Locations
Germany
Glycotope Investigational Site
Hamburg, Germany, D-20246
Glycotope Investigational Site
Heidelberg, Germany, D-69120
Italy
Glycotope Investigational Site
Milan, Italy, 20133
Glycotope Investigational Site
Milan, Italy, 20132
Switzerland
Glycotope Investigational Site
Bellinzona, Switzerland, CH-6500
Sponsors and Collaborators
Glycotope GmbH
Investigators
Study Director: Glycotope GmbH Glycotope GmbH
  More Information

No publications provided

Responsible Party: Glycotope GmbH
ClinicalTrials.gov Identifier: NCT01222637     History of Changes
Other Study ID Numbers: GEXMab52101
Study First Received: October 15, 2010
Last Updated: December 16, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Glycotope GmbH:
advanced solid cancers
metastatic solid cancers

ClinicalTrials.gov processed this record on April 15, 2014