Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Ombrabulin (AVE8062), AVE8062
Ombrabulin · 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...
Top 20 of 31 competitors
Ombrabulin is an investigational small molecule oncology drug developed by Sanofi. It has been studied in clinical trials for advanced solid tumors, non-small cell lung cancer, recurrent ovarian cancer, and sarcoma. It is not approved and remains in clinical development.
Ombrabulin has been evaluated in clinical trials for advanced solid tumors, malignant neoplasms, non-small cell lung cancer, recurrent ovarian cancer, and sarcoma. It is an investigational agent and is not approved for any indication.
Ombrabulin targets tubulin proteins, specifically TUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, and TUBA1A. It acts as an inhibitor of these targets, which are components of microtubules involved in cell division.
Ombrabulin is developed by Sanofi, which trades under the ticker SNY. Sanofi has sponsored clinical trials of the drug in multiple countries.
Ombrabulin is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any regulatory agency.
Ombrabulin has been studied in four completed clinical trials: NCT01332656 in platinum-sensitive recurrent ovarian cancer, NCT01293630 in advanced solid tumors, NCT01263886 in non-small cell lung cancer, and NCT01193595 in malignant neoplasms. All trials are completed and no trials are currently active.
Yes, Ombrabulin is also known as AVE8062. Both names refer to the same investigational small molecule developed by Sanofi.