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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014