Status:
TERMINATED
Study to Evaluate Progression Free Survival in Cancer Patients With Advanced Colorectal Carcinoma With AMT2003
Lead Sponsor:
Auron Healthcare GmbH
Conditions:
Colorectal Carcinoma
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
PHASE3
Brief Summary
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 ...
Detailed Description
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 se...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00405561
Start Date
October 1 2006
End Date
January 1 2010
Last Update
March 20 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinic SanaFontis
Freiburg im Breisgau, Germany, 79111