Study to Evaluate Progression Free Survival in Cancer Patients With Advanced Colorectal Carcinoma With AMT2003

Study Overview
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Brief Summary
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The purpose of the study is to evaluate efficacy and safety of AMT2003 in cancer patients with advanced colorectal carcinoma. The primary endpoint is progression free survival rate at 18 weeks after registration

Detailed Description
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The study will include patients with advanced colorectal carcinoma that is refractory to standard therapy or for which no effective standard therapy exists. Eligible patients must have had at least second-line chemotherapy.

Official Title
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A Prospective, Open, Single-Arm, Multicenter Phase II Clinical Trial to Evaluate the Progression Free Survival and Safety in Patients With Advanced Colorectal Carcinoma Treated With AMT2003

Conditions
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Colorectal 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 in the 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 |
| --- | --- | --- |
| Progression free survival;at 18 weeks after registration |  | 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best overall response rate (ORR, CR and PR) within 18 weeks after registration |  | 2010 | 
| Progression Free survival time (PFS), over complete observation period |  | 2010 | 
| Overall Survival (OS) time |  | 2010 | 
| Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index) |  | 2010 | 
| Safety and Tolerability |  | 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Colorectal Carcinoma