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

Sponsor

MediGene (Industry)

Overall Status

Completed

CT.gov ID

NCT00542048

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Liver Cancer Neoplasm Metastasis	Drug: EndoTAG®-1	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: EndoTAG®-1 EndoTAG®-1 22 mg/m² twice weekly

Arm

Intervention/Treatment

Experimental: 1

Drug: EndoTAG®-1

EndoTAG®-1 22 mg/m² twice weekly

Outcome Measures

Primary Outcome Measures

Pharmacokinetic profile [Last patient out]

Secondary Outcome Measures

Tumor response, Tumor perfusion, Soluble markers of angiogenesis, Pharmacodynamics, Safety [Last patient out]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Klinik für Internistische Onkologie in der KTB Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg	Freiburg Im Breisgau	Baden-Würtemberg	Germany	79106