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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2009-011142-26 | Registry Identifier | EudraCT |
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The purpose of this study is to determine the effect of the ASA404 infusion rate and co-administrating ASA404 with paclitaxel + carbopaltin chemotherapy regimen or docetaxel on the pharamcokinetics (PK) of free and total ASA404.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASA404 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASA404 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pK of a single intravenous dose of ASA404 1200 and 1800 mg/m2 monotherapy in adult cancer patients with impaired renal function compared to matching patients with normal renal function | 12 monnths |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics of a single i.v. dose of ASA 1200 and 1800 mg/m2 +chemotherapy (doctaxel or paclitaxel + carboplatin) in adult cancer patients with impaired renal function compared to matching patients with normal renal function | 12 months | |
| To assess the safety and tolerability of ASA404 in adult cancer patients with impaired renal function compared to matching patients with normal renal function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Charleroi | Belgium | ||||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CASA404A2112 can be found on the Novartis Clinical Trial Results Website | View source |
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| 12 months |
| To assess the safety and tolerability of ASA404 1200 or 1800 mg/m2 in combination with chemotherapy (docetaxel or paclitaxel + carboplatin) | 12 months |
| To evaluate ASA404 pharmacokinetic parameters including AUC (0-t last),), AUC (0-inf)), T ((½)), CL, V(Z), Cmax, and Tmax | 12 months |
| To evaluate renal clearance (CLR) of ASA404. | 12 months |
| Jette |
| Belgium |
| Novartis Investigative Site | Saint-Lambert | Belgium |
| Novartis Investigative Site | Wilrijk | Belgium |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C066668 | vadimezan |
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