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

Primary Purpose

Liver Cancer, Neoplasm Metastasis

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

EndoTAG®-1

About this trial

This is an interventional basic science trial for Liver Cancer focused on measuring Hepatic metastases, Angiogenesis, EndoTAG-1, Pharmacokinetics, Pharmacodynamics, Metastases of the liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Klinik für Internistische Onkologie in der KTB Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Pharmacokinetic profile

Secondary Outcome Measures

Tumor response, Tumor perfusion, Soluble markers of angiogenesis, Pharmacodynamics, Safety

Full Information

NCT ID

NCT00542048

First Posted

October 9, 2007

Last Updated

February 8, 2010

Sponsor

MediGene

1. Study Identification

Unique Protocol Identification Number

NCT00542048

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

MediGene

4. Oversight

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cancer, Neoplasm Metastasis

Keywords

Hepatic metastases, Angiogenesis, EndoTAG-1, Pharmacokinetics, Pharmacodynamics, Metastases of the liver

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

EndoTAG®-1

Intervention Description

EndoTAG®-1 22 mg/m² twice weekly

Primary Outcome Measure Information:

Title

Pharmacokinetic profile

Time Frame

Last patient out

Secondary Outcome Measure Information:

Title

Tumor response, Tumor perfusion, Soluble markers of angiogenesis, Pharmacodynamics, Safety

Time Frame

Last patient out

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Klaus Mross, PD

Organizational Affiliation

Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinik für Internistische Onkologie in der KTB Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg

City

Freiburg Im Breisgau

State/Province

Baden-Würtemberg

ZIP/Postal Code

79106

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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