Trial Information

Summary: Study to evaluate the clinical benefit response of a new drug AMT vs Placebo in advanced cancer patients with esophagus, colon, pancreas, lung, gastric, liver, gall bladder, prostate and female reproductive system cancers

The aim of the study is to investigate a new medicine called AMT. This drug is currently being used in clinical trials to treat cancer patients. In many of these patients, an improvement in general well-being and quality of life was observed. In order to validate these early findings, the present study is being conducted.

The study will be conducted as a double-blind, placebo controlled study. This means that half the patients will receive the AMT while the other half will receive a preparation that contains non active substance (called placebo). Patients will be assigned at random to either of these treatment groups. Both AMT or placebo will be administered twice daily intramuscularly.

Initially, patients will receive the treatment for 8 or 12 weeks. Those patients who benefit from the treatment will be permitted to continue the treatment if they wish. However, the duration of the treatment is limited to a maximum of 29 months.

Patients in the study will be given a medical examination before the first dose. A CT or MRI scan will also be performed in order to determine the extent of spread of cancer in the body. Blood and urine samples will be taken for routine laboratory measurements. An ECG will be used to record heart function.

Patients will undergo periodic physical examination , should they continue to be in the study. Blood and urine samples as well as CT scans or MRI will also be taken periodically during the treatment period.

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 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 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

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.