Study to Evaluate Progression Free Survival in Cancer Patients With Advanced Colorectal Carcinoma With AMT2003
Basic Trial Information Trial Description Summary Further Trial Information Eligibility Criteria Trial Contact Information
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase III, Phase II | Treatment | Active | 18 to 79 | AMT/P2GI/001 Part III LC001Auron2005, NCT00405561 |
Trial Description
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 registration Further Study Information The study will include patients with advanced colorectal carcinoma that is refractory to standard therapy or for which no effective stabdard therapy exists. Eligible patients must have had at least second-line chemotherapy. Eligibility Criteria 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 atleast 3 months
Exclusion Criteria: - Known secondary neoplasia or central nervous system (CNS) metastases; acute or chronic leukemia, lymphoma or multiple myeloma
- 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
Trial Contact Information
Trial Lead Organizations/Sponsors Auron Healthcare GmbH Joachim Drevs, PD Dr. med. | ![](https://webarchive.library.unt.edu/eot2008/20090510205402im_/http://www.cancer.gov/images/spacer.gif) | Principal Investigator |
Trial Sites
![](https://webarchive.library.unt.edu/eot2008/20090510205402im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20090510205402im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20090510205402im_/http://www.cancer.gov/images/spacer.gif) |
![](https://webarchive.library.unt.edu/eot2008/20090510205402im_/http://www.cancer.gov/images/spacer.gif) |
Germany |
![](https://webarchive.library.unt.edu/eot2008/20090510205402im_/http://www.cancer.gov/images/spacer.gif) |
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Freiburg im Breisgau |
![](https://webarchive.library.unt.edu/eot2008/20090510205402im_/http://www.cancer.gov/images/spacer.gif) |
| | | | | | | Klinik Sana Fontis |
| | Joachim Drevs, PD Dr. Med |
Ph: +49-761-888-595959 |
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Email:
drevs@sanafontis.com 5 |
| | Joachim Drevs, PD Dr. Med | Principal Investigator |
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Link to the current ClinicalTrials.gov record. 6
NLM Identifer NCT00405561 Information obtained from ClinicalTrials.gov on March 18, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
Table of Links
1 | http://www.cancer.gov/clinicaltrials/learning |
2 | http://www.cancer.gov/cancertopics/factsheet/Information/clinical-trials |
3 | http://www.cancer.gov/clinicaltrials/learning/questions-to-ask-about-participat ing |
4 | http://www.nlm.nih.gov/medlineplus/druginformation.html |
5 |
mailto:drevs@sanafontis.com?Subject=NCT00405561,AMT/P2GI/ 001 Part III:- Study to Evaluate Progression Free Survival in Cancer Patients With Advanced Colorectal Carcinoma With AMT2003 |
6 | http://clinicaltrials.gov/show/NCT00405561 |
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