A Trial Evaluating the Pharmacokinetics and Mode of Action of EndoTAG®-1 in Tumor Patients With Hepatic Metastases - Full Text View

Sponsor:	MediGene
Information provided by:	MediGene
ClinicalTrials.gov Identifier:	NCT00542048

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

U.S. FDA Resources

Further study details as provided by MediGene:

Primary Outcome Measures:

Pharmacokinetic profile [ Time Frame: Last patient out ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tumor response, Tumor perfusion, Soluble markers of angiogenesis, Pharmacodynamics, Safety [ Time Frame: Last patient out ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	November 2007
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: EndoTAG®-1 EndoTAG®-1 22 mg/m² twice weekly

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Unresectable hepatic metastases of a carcinomatous origin with exception of HCC, biliary or bile duct carcinoma
At least one measurable hepatic metastases > 20 mm in diameter (measured in MRI)
Last application of palliative chemotherapy (drug dependent on the primary tumor) at least 7 days ago
Gender: male and female (at least 6 individuals of each gender)
Age >= 18 years
Negative pregnancy test (females of childbearing potential)
Willingness to perform double-barrier-contraception during the study and for 6 month post study medication
ECOG performance status 0,1 or 2
Assumed life expectancy of > 3 month
Signed informed consent

Exclusion Criteria:

History of significant liver pathology (other than metastases, e.g. cirrhosis of the liver, PSC, PBC) or liver transplantation
Laboratory tests (hematology, chemistry) outside specific limits:
ANC <= 1.0 x 10^9/L
Platelets <= 100 x 10^9/L
Hb <= 9.0 g/dL (<= 5.6 mmol/L)
Total Bilirubin > 2.0 mg/dL
Serum Creatinine > 1.5 mg/dL
Renal insufficiency with a GFR < 60 mL/min
Currently ongoing taxane-containing palliative chemotherapy regimen or history of taxane administration within 4 weeks prior to study entry
Pregnancy or nursing status
Positive HIV, HBV or HCV testing
The patient has a contraindication for MRI or CEUS according to accepted clinical guidelines
Known hypersensitivity to any component of the EndoTAG®-1 formulation, gadolinium-based MR-contrast media or sulphur hexafluoride
Claustrophobia or history of active or significant neurological disorder and/or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of the patient during the trial
Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542048

Locations

Germany, Baden-Würtemberg
Klinik für Internistische Onkologie in der KTB Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg
Freiburg Im Breisgau, Baden-Würtemberg, Germany, 79106

Sponsors and Collaborators

MediGene

Investigators

Principal Investigator:

Klaus Mross, PD

Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg

More Information

No publications provided

Responsible Party:	MediGene ( Dr. Carola Adam/Clinical Project Leader )
Study ID Numbers:	CT 4003
Study First Received:	October 9, 2007
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00542048 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by MediGene:

Hepatic metastases
Angiogenesis
EndoTAG-1

Pharmacokinetics
Pharmacodynamics
Metastases of the liver

Additional relevant MeSH terms:

Liver Neoplasms
Neoplastic Processes
Liver Diseases
Neoplasms
Pathologic Processes

Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Neoplasm Metastasis

ClinicalTrials.gov processed this record on November 30, 2009