hepatic metastases in patients with a carcinomatous primary tumor other than hepatocellular (HCC), biliary or bile duct carcinoma MedDRA version: 9.1 Level: LLT Classification code 10027457 Term: Metastases to liver
Conditions
Interventions
Product Name: EndoTAG-1
Product Code: MDG 09.108
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Paclitaxel
CAS Number: 33069-62-4
Concentration unit: mg milligram(s)
Concen
Sponsors
MediGene AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the pharmacokinetic profile of EndoTAG-1 (22mg/m²) after single-dose and in steady-state ;Secondary Objective: -To assess the effect of EndoTAG-1 on target liver metastases perfusion and vascular permeability -To assess the effect of EndoTAG-1 on soluble blood markers of angiogenesis -To assess the correlation between metastases perfusion and the pharmacokinetic profile -To gain further safety data;Primary end point(s): -Pharmacokinetic profile: C max, t max, t ½ term, AUC 0-t, AUC 0-inf, VD and CL for paclitaxel, 6a-OH-paclitaxel and DOTAP •Secondary endpoints: - Kep, Ktrans, iAUC60, iAUC90 and iAUC120, of dynamic blood flow in target hepatic metastases and ADC: Number of subjects with decrease, no change or increase between Screening (Baseline) and all post baseline time points measured in DCE-MRI | — |
Countries
Germany
Outcome results
None listed