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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2009-017159-88 | Registry Identifier | EudraCT |
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The purpose of this study is to evaluate the safety and pharmacokinetics of ASA404 in patients with refractory or relapsed metastatic cancer with impaired renal function and with normal renal function. It is very possible that patients with renal impairment will show differences in renal excretion of parent ASA404 and its metabolites, warranting a study that leads to a better pharmacokinetic assesssment in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASA404 + standard therpy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASA404, DMXAA or DXAA | 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 months |
| 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 Investigative Site | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin and Bren Simon Cancer Center, Hematology/Oncology Dept. | Indianapolis | Indiana | 46202 | United States | ||
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| Label | URL |
|---|---|
| Results for CASA404A2109 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) |
| To evaluate ASA404 pharmacokinetic parameters including AUC (0-t last),), AUC (0-inf)), T ((½)), CL, V(Z), Cmax, and Tmax |
| To evaluate renal clearance (CLR) of ASA404. |
| Hematology /Oncology Associates |
| Rockville |
| Maryland |
| 20850 |
| United States |
| Joseph Ford Cancer Center/Clinical Trials Office, Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109-1023 | United States |
| 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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