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Also known as Ombrabulin
AVE8062 · 11 trials · 8 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Arm A | EXPERIMENTAL | Ombrabulin, Paclitaxel and Carboplatin |
| Arm B | PLACEBO_COMPARATOR | Placebo, Paclitaxel and Carboplatin |
| AVE8062 and combination | EXPERIMENTAL | Day 1: AVE8062 Day 2: docetaxel followed by cisplatin or paclitaxel followed by carboplatin |
| Placebo | PLACEBO_COMPARATOR | Day 1: placebo Day 2: docetaxel followed by cisplatin or paclitaxel followed by carboplatin |
| Cohort - 1 through 5 | EXPERIMENTAL | AVE8062 combined with paclitaxel and carboplatin will be administered once every 3 weeks |
| AVE8062/ bevacizumab | EXPERIMENTAL | The combination of ombrabulin and bevacizumab will be administered every 3 weeks according to the following schedule: One day 1, ombrabulin will be administered as a 30 minutes intravenous (i.v) infusion. Bevacizumab will be administered as a 30-90 minutes i.v. infusion 24 hours after the end of ombrabulin infusion on day 2. |
| Ombrabulin/ docetaxel/cisplatin | EXPERIMENTAL | AVE8062 combined with docetaxel and cisplatin will be administered once in every 3 weeks, with 30-minute intravenous infusion |
| Ombrabulin/cisplatin | EXPERIMENTAL | AVE8062 combined with 75 mg/m2 of cisplatin will be administered once in every 3 weeks, with 30-minute intravenous infusion |
| [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. |
| AVE8062 / Docetaxel | EXPERIMENTAL | AVE8062 30-minute IV, 11.5 to 42 mg/m2, followed by Docetaxel, 1-hour IV, 75 and 100 mg/m2 in 3-week cycles until disease progression or unacceptable toxicity or study discontinuation criteria |
| Name | Type | Description |
|---|---|---|
| OMBRABULIN (AVE8062) | DRUG | I.V. infusion followed by administration of cisplatin |
| Placebo | DRUG | I.V. infusion followed by administration of cisplatin |
| Paclitaxel | DRUG | Pharmaceutical form:solution Route of administration: intravenous |
| Carboplatin | DRUG | Pharmaceutical form:solution Route of administration: intravenous |
| bevacizumab | DRUG | Pharmaceutical form:Solution for infusion Route of administration: Intravenous |
| cisplatin | DRUG | Pharmaceutical form:injection solution Route of administration: intravenous infusion |
| docetaxel | DRUG | Pharmaceutical form:injection solution Route of administration: intravenous infusion |
| AVE8062 | DRUG | Pharmaceutical form:Solution for infusion Route of administration: Intravenous |
Inclusion criteria: * Histologically proven soft tissue sarcoma * Unresectable locoregional recurrent or metastatic soft tissue sarcoma * Failure of a previous anthracycline-based regimen administered recommended dose and of prior ifosfamide therapy Exclusion criteria: * Less than 3 weeks elapsed...
AVE8062 is an investigational small molecule being studied for the treatment of advanced neoplastic disease, a type of cancer. It is currently in clinical development and has not been approved by regulatory authorities. The drug is being evaluated in patients with advanced solid tumors.
AVE8062 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this investigational oncology drug.
AVE8062 is in Phase 1 clinical development. This early-stage trial is designed to assess the drug's safety, tolerability, and pharmacokinetics in patients with advanced solid tumors. The drug is investigational and has not yet received regulatory approval.
AVE8062 has one completed clinical trial registered under NCT01907685. This Phase 1 study, titled "Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Docetaxel in Patients With Advanced Solid Tumors," enrolled 58 participants with advanced neoplastic disease.
AVE8062 is being studied in a Phase 1, open-label, uncontrolled clinical trial. The study combines AVE8062 with docetaxel in patients with advanced solid tumors. The trial is not randomized or double-blinded, and it does not use a control group or biomarker selection.