The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced disease. The primary evaluation criterion is clinical benefit response.
The study will include patients with a variety of solid tumors (i.e. esophageal, colon, pancreatic, bronchial, gastric, hepatocellular, gall bladder, prostate and gynaecological carcinomas.) The clinical benefit response - CBR, is an end point that provides a clinical measure for symptom improvement in patients. The key evaluation parameters for CBR will be assessment of pain, the ability to perform daily activities and weight change.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Klinicki Centar Univerziteta Sarajevo - Klinika za gastroenterohepatologiju
Sarajevo, Bosnia and Herzegovina
Clinic SanaFontis
Freiburg im Breisgau, Germany
Improvement in clinical benefit response
Time frame: Jan 2010
Progression free survival
Time frame: Jan 2010
Overall survival
Time frame: Jan 2010
Overall response rate
Time frame: 2010
Duration of response
Time frame: January 2010
Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30])
Time frame: Jan 2010
Safety and tolerability
Time frame: Jan 2010
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