Study to Evaluate Tumour Response in Cancer Patients With Advanced Hepatocellular Carcinoma (Liver Cancer) With AMT2003

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 primary hepatocellular carcinoma The primary endpoint is best overall response rate within 20 weeks after registration

Detailed Description
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The study will include patients with advanced primary hepatocellular carcinoma refractory to standard therapy or for which no effective standard therapy exists. The best overall response rate is the best response recorded from the start of treatment until disease progression / recurrence.

Official Title
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A Prospective, Open, Single-arm, Multicenter Phase II Clinical Trial to Evaluate the Tumour Response and Safety in Patients With Advanced Primary Hepatocellular Carcinoma Treated With AMT2003

Conditions
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Hepatocellular Carcinoma

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 of 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 method of birth control 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 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
Allocation: Non-Randomized
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 |
| --- | --- | --- |
| Best overall tumour response according to RECIST; within 20 weeks after registration; confirmation 6 +/- weeks later |  | March 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) time |  | March 2010 | 
| Overall Survival (OS) time |  | March 2010 | 
| Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index) |  | March 2010 | 
| Safety and Tolerability |  | March 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary hepatocellular carcinoma, Liver cancer, Tumour response, Quality of life