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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2007-004038-18-DE |
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Date of registration:
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11/09/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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04/10/2007 |
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Target sample size:
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20 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004038-18 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised:
Open: yes
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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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
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Intervention(s)
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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)
Concentration type: equal
Concentration number: 6.4-
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Primary Outcome(s)
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Main Objective: To assess the pharmacokinetic profile of EndoTAG-1 (22mg/m²) after single-dose and in steady-state
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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
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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
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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