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

Conditions: hepatic metastases in patients with a carcinomatous primary tumor other than hepatocellular (HCC), biliary or bile duct carcinoma
MedDRA version: 9.1Level: LLTClassification code 10027457Term: Metastases to liver

Registration Number: EUCTR2007-004038-18-DE

Lead Sponsor: MediGene AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of significant liver pathology (other than metastases, e.g. cirrhosis of the liver, PSC, PBC) or liver transplantation
2. 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
3. Renal insufficiency with a GFR < 60 mL/min
4. Currently ongoing taxane-containing palliative chemotherapy regimen or history of taxane administration within 4 weeks prior to randomization
5. Pregnancy or nursing status
6. Positive HIV, HBV or HCV testing
7. The patient has a contraindication for MRI ôr CEUS according to accepted clinical guidelines
8. Known hypersensitivity to any component of the EndoTAG®-1 formulation or gadolinium-based MR-contrast media or sulphur hexafluoride
9. 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
10. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method