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Primary Objective:
Secondary Objectives:
The duration of the study for each patient will include an up to 4-week screening phase, 21-day study treatment cycles, an end of treatment visit and a follow-up period 30 days after the last infusion of ombrabulin. The patient will continue treatment until disease progression, unacceptable toxicity, patient's refusal of further treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ombrabulin/cisplatin | Experimental | AVE8062 combined with 75 mg/m2 of cisplatin will be administered once in every 3 weeks, with 30-minute intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ombrabulin (AVE8062) | Drug | Pharmaceutical form:injection solution Route of administration: intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity | 3 weeks (cycle 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Global safety profile based on treatment emergent adverse events, serious adverse events, and laboratory abnormalities | on-treatment period + 30 days | |
| Pharmacokinetic parameters of AVE8062 | Cycle 1 : Day 1 and 2; up to Cycle 4 : Day 1 |
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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 | Tokyo | Japan |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C400245 | AC 7700 |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| cisplatin | Drug | Pharmaceutical form: injection solution Route of administration: intravenous infusion |
|
| Pharmacokinetic parameters of cisplatin | Day 1 to 4 of Cycle 1 |
| Pharmacokinetic parameters of AVE8062's active metabolite RPR258063 | Cycle 1 : Day 1 and 2; up to Cycle 4 : Day 1 |
| Objective tumor response as defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | up to a maximum of 11 months |