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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1116-5905 | Other Identifier | UTN |
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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/ docetaxel/cisplatin | Experimental | AVE8062 combined with docetaxel and 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 profiles of all study drugs and AVE8062 active metabolite based on PK parameters (Cmax, AUC, t1/2, CL, Vss). |
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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 |
|---|---|---|---|---|---|---|
| Investigational Site Number 392003 | Akashi-Shi | Japan | ||||
| Investigational Site Number 392001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29514256 | Derived | Nishio M, Satouchi M, Horiike A, Horio Y, Sunaga Y, Ecstein-Fraisse E, Hida T. Phase 1 study of ombrabulin in combination with docetaxel and cisplatin in Japanese patients with advanced solid tumors. Jpn J Clin Oncol. 2018 Apr 1;48(4):322-328. doi: 10.1093/jjco/hyy026. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C400245 | AC 7700 |
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| 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 |
|
| docetaxel | Drug | Pharmaceutical form:injection solution Route of administration: intravenous infusion |
|
| Cycle 1: Day 1 and 3; up to Cycle 4: Day 1 |
| Objective tumor response as defined by the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | on-treatment period + 30 days |
| KÅtoku |
| Japan |
| Investigational Site Number 392002 | Nagoya | Japan |
| D043823 |
| Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |