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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer, Neoplasm Metastasis

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Pharmacokinetic profile

Outcome Time Frame:

Last patient out

Safety Issue:

No

Principal Investigator

Klaus Mross, PD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CT 4003

NCT ID:

NCT00542048

Start Date:

November 2007

Completion Date:

September 2009

Related Keywords:

  • Liver Cancer
  • Neoplasm Metastasis
  • Hepatic metastases
  • Angiogenesis
  • EndoTAG-1
  • Pharmacokinetics
  • Pharmacodynamics
  • Metastases of the liver
  • Neoplasms
  • Liver Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary

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