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Sponsored by: |
Auron Healthcare GmbH |
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Information provided by: | Auron Healthcare GmbH |
ClinicalTrials.gov Identifier: | NCT00405561 |
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
Condition | Intervention | Phase |
---|---|---|
Colorectal Carcinoma |
Drug: AMT2003 |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 67 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | June 2009 |
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.
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Joachim Drevs, PD Dr. med. | +49-761-888-595959 | drevs@sanafontis.com |
Germany | |
Clinic SanaFontis | Recruiting |
Freiburg im Breisgau, Germany, 79111 | |
Contact: Joachim Drevs, PD Dr. Med +49-761-888-595959 drevs@sanafontis.com | |
Principal Investigator: Joachim Drevs, PD Dr. Med |
Principal Investigator: | Joachim Drevs, PD Dr. med. | Clinic Sanafontis, Freiburg |
Study ID Numbers: | AMT/P2GI/001 Part III, LC001Auron2005 |
Study First Received: | November 29, 2006 |
Last Updated: | November 29, 2006 |
ClinicalTrials.gov Identifier: | NCT00405561 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Advanced Colorectal Carcinoma |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Disease Progression Gastrointestinal Neoplasms |
Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |