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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 Sponsor Protocol IDs
Phase III, Phase II Treatment Active 18 to 79 Pharmaceutical / Industry 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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Auron Healthcare GmbH

Joachim Drevs, PD Dr. med.

Principal Investigator

Joachim Drevs, PD Dr. med.		Ph: +49-761-888-595959
		Email: drevs@sanafontis.com

Trial Sites

Germany

Freiburg im Breisgau

Klinik Sana Fontis

Joachim Drevs, PD Dr. Med Ph: +49-761-888-595959

Email: drevs@sanafontis.com

Joachim Drevs, PD Dr. Med Principal Investigator

Link to the current ClinicalTrials.gov record.
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.