EUCTR2007-004038-18-DE
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- MediGene AG
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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