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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007824-24 | EudraCT Number |
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Primary Objectives:
Secondary Objective:
The duration of the study for each patient will include approximately 4 weeks of a screening phase prior to first infusion of study drug, 21-day study treatment cycles and end of treatment visit. The patient can continue treatment until disease progression, unacceptable toxicity, or the patient's refusal of further treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-AVE8062 | Experimental | Single, 30 minute, intravenous infusion of 25 mg/m² of [14C]-AVE8062 containing 1.85 MBq (50µCi) at the first cycle, followed by subsequent administrations with non-radiolabelled AVE8062 in combination with cisplatin every 3 weeks, according to the investigator's judgment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ombrabulin (AVE8062) | Drug | Pharmaceutical form:concentrate solution Route of administration: intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of radioactive dose excreted in urine, feces and expired air | 3 weeks (end of cycle 1) or 30 days after the first dose | |
| Concentration-time profiles and pharmacokinetic (PK) parameters of total radioactivity in whole blood and plasma; blood over plasma concentration ratios; Concentration-time profile and PK parameters of AVE8062 and RPR258063 in plasma | 3 weeks (end of cycle 1) or 30 days after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment based on Adverse events reporting, laboratory tests according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTC) v3.0 grade scaling | 3 weeks (end of cycle 1) or 30 days after the first dose |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Brussels | Belgium |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C400245 | AC 7700 |
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