A Trial Evaluating the Pharmacokinetics and Mode of Action of EndoTAG®-1 in Tumor Patients With Hepatic Metastases
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ClinicalTrials.gov Identifier: NCT00542048 |
Recruitment Status
:
Completed
First Posted
: October 10, 2007
Last Update Posted
: February 9, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Liver Cancer Neoplasm Metastasis | Drug: EndoTAG®-1 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | 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 |
Study Start Date : | November 2007 |
Actual Primary Completion Date : | September 2009 |
Actual Study Completion Date : | September 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: EndoTAG®-1
EndoTAG®-1 22 mg/m² twice weekly
|
- Pharmacokinetic profile [ Time Frame: Last patient out ]
- Tumor response, Tumor perfusion, Soluble markers of angiogenesis, Pharmacodynamics, Safety [ Time Frame: Last patient out ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542048
Germany | |
Klinik für Internistische Onkologie in der KTB Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg | |
Freiburg Im Breisgau, Baden-Würtemberg, Germany, 79106 |
Principal Investigator: | Klaus Mross, PD | Klinik für Tumorbiologie an der Albert-Ludwigs-Universität Freiburg |
Responsible Party: | Dr. Carola Adam/Clinical Project Leader, MediGene |
ClinicalTrials.gov Identifier: | NCT00542048 History of Changes |
Other Study ID Numbers: |
CT 4003 |
First Posted: | October 10, 2007 Key Record Dates |
Last Update Posted: | February 9, 2010 |
Last Verified: | November 2009 |
Keywords provided by MediGene:
Hepatic metastases Angiogenesis EndoTAG-1 |
Pharmacokinetics Pharmacodynamics Metastases of the liver |
Additional relevant MeSH terms:
Neoplasm Metastasis Neoplasms, Second Primary Liver Neoplasms Neoplastic Processes Neoplasms Pathologic Processes Digestive System Neoplasms Neoplasms by Site Digestive System Diseases |
Liver Diseases Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |