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Sponsored by: |
MediGene |
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Information provided by: | MediGene |
ClinicalTrials.gov Identifier: | NCT00542048 |
The primary objective of study CT 4003 is to assess the behavior of EndoTAG®-1 in the body (making a so-called pharmacokinetic profile). Therefore, the course of the drug in the body is examined, i.e. the amount and speed of the drug uptake as well as the distribution and the elimination of the drug is being investigated. Further objectives of the study are to assess the effect of EndoTAG®-1 on liver metastases concerning size and blood supply measured by imaging techniques (contrast-enhanced ultrasound and magnetic resonance imaging as well as duplex sonography) and to assess the effect on blood markers which are indicators for the destruction and neoplasm of blood vessels (so-called markers of angiogenesis).
Condition | Intervention | Phase |
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Liver Cancer Neoplasm Metastasis |
Drug: EndoTAG®-1 |
Phase II |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | An Open-Label, Uncontrolled, Phase II Trial Evaluating the Single-Dose and Steady-State Pharmacokinetics of EndoTAG®-1 and Its Effect on the Blood Supply and the Angiogenesis of Hepatic Metastases in Patients With a Carcinomatous Primary Tumor Other Than Hepatocellular (HCC), Biliary or Bile Duct Carcinoma |
Estimated Enrollment: | 20 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: EndoTAG®-1
EndoTAG®-1 22 mg/m² twice weekly
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Liver metastases are among the most frequent neoplasms of the liver and represent a quite uniform clinical entity regardless from which carcinoma they originate. The treatment is dependent on number and size of the hepatic lesions but still, none of the therapeutic options leads to satisfying results. The growth of tumors and metastases is dependent on blood vessels, which supply the tumors and metastases with nutrients. Liver metastases, independent from which original tumor they come from, are especially well supplied with blood. The aim of the treatment with the investigational medicinal product EndoTAG®-1 is to target the blood vessels, which supply the metastases, and destroy them. Consequently, the metastases themselves will be damaged.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Carola Adam, Dr. | 0049-89-8565-2991 | c.adam@medigene.com |
Contact: Matthias Karrasch, Dr. | 0049-89-8565-2914 | m.karrasch@medigene.com |
Germany, Baden-Würtemberg | |
Klinik für Internistische Onkologie in der KTB Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg | Recruiting |
Freiburg im Breisgau, Baden-Würtemberg, Germany, 79106 |
Principal Investigator: | Klaus Mross, PD | Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg |
Responsible Party: | MediGene ( Dr. Matthias Karrasch/Medical Expert ) |
Study ID Numbers: | CT 4003 |
Study First Received: | October 9, 2007 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00542048 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Hepatic metastases Angiogenesis EndoTAG-1 |
Pharmacokinetics Pharmacodynamics Metastases of the liver |
Carcinoma, Ductal Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms |
Liver neoplasms Neoplasm Metastasis Gastrointestinal Neoplasms Carcinoma, Ductal, Breast Carcinoma |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |