Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus Placebo

A Prospective, Randomised, Multicenter Phase II/III Clinical Trial to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT Versus Placebo

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.

Inclusion Criteria:

• Cancer confirmed by histology or cytology
• At least one measurable lesion
• Advanced disease refractory to standard therapy or for which no standard therapy exists
• Life expectancy at least 3 months

Exclusion Criteria:

• Known secondary neoplasia or central nervous system (CNS) metastases, acute or chronic leukemia, lymphoma or multiple myeloma
• Body weight below 45 kg
• Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective birth control methods
• Concurrent severe or uncontrolled medical disease
• Acute or chronic liver disease
• Confirmed diagnosis of HIV
• Insulin dependent diabetes mellitus/abnormal glucose tolerance test (GTT)/latent diabetes mellitus type I or II
• Chemotherapy or radiotherapy less than 4 weeks prior to entry
• Surgery less than 2 weeks prior to entry (or not recovered from effects of surgery)
• Participation in a clinical trial less than 30 days prior to entry into this study