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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Gastrointestinal Cancer, Prostate Cancer, Genital Neoplasms, Female

Intervention / Treatment
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* Drug: AMT2003


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMT2003<br> | Drug: AMT2003<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in clinical benefit response |  | Jan 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | Jan 2010 | 
| Overall survival |  | Jan 2010 | 
| Overall response rate |  | 2010 | 
| Duration of response |  | January 2010 | 
| Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]) |  | Jan 2010 | 
| Safety and tolerability |  | Jan 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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solid tumors, clinical benefit, quality of life, esophageal cancer, colon cancer, pancreatic cancer, gastric cancer, liver cancer, gall bladder cancer, prostate cancer, gynecological cancer, lung cancer, Tumors of GI tract, prostate and gynaecological