Status:
COMPLETED
Safety and Tolerability Study of Claudiximab in Patients With Advanced Gastroesophageal Cancer
Lead Sponsor:
Ganymed Pharmaceuticals GmbH
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Claudiximab is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. Preclinically, claudiximab was shown to inhibit tumor growth and to kill cancer cells by indirect (compl...
Eligibility Criteria
Inclusion
- Metastatic, refractory or recurrent disease of advanced gastroesophageal cancer (adenocarcinoma) proven by histology
- CLDN18.2 expression confirmed by immunohistochemistry
- Prior standard chemotherapy containing a fluoropyrimidine, a platinum compound and/or epirubicine, and - if clinically appropriate - docetaxel
- At least 1 measurable site of the disease according RECIST criteria (CT-scans or MRT not older than 6 weeks before study entry)
- Age ≥ 18 years
- ECOG performance status (PS) 0-1 or Karnofsky Index 70-100%
- Life expectancy \> 3 months
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dl
- INR \< 1.5
- Bilirubin normal
- AST and ALT \< 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- Creatinine \< 1.5 x ULN
Exclusion
- Pregnancy or breastfeeding
- Prior allergic reaction or intolerance to a monoclonal antibody
- Prior inclusion in the present study
- Less than 3 weeks since prior anti-tumor or radiation therapy
- Other investigational agents or devices concurrently or within 4 weeks prior to this study
- Other concurrent anticancer therapies
- History of positive test for human immunodeficiency virus (HIV) antibody
- Known Hepatitis.
- Uncontrolled or severe illness.
- Concurrent administration of anticoagulation agents with vitamin K antagonists
- Concurrent administration of therapeutic doses of heparin (prophylactic doses are acceptable)
Key Trial Info
Start Date :
May 31 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00909025
Start Date
May 31 2009
End Date
May 31 2010
Last Update
November 21 2024
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitätsklinikum Essen, Innere Klinik (Tumorforschung)
Essen, Germany, 45122
2
Universität Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, Germany, 69120
3
Johannes Gutenberg Universität, 1.Med Klinik und Poliklinik
Mainz, Germany, 55131
4
Klinikum Rechts-der-Isar, III.Medizinische Klinik und Poliklinik
München, Germany, 81674