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OMBRABULIN · 10 trials · 7 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. |
| 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 |
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...
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Ombrabulin is an investigational small molecule being studied for the treatment of advanced solid tumors, non-small cell lung cancer, and recurrent ovarian cancer. It has been evaluated in clinical trials for these oncology indications, though it remains in clinical development and is not approved.
Ombrabulin is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi has sponsored clinical trials of Ombrabulin across multiple countries and patient populations.
Ombrabulin has completed Phase 1 and Phase 2 clinical trials. It has been studied in four completed trials, including Phase 1 dose-escalation studies and Phase 2 trials in non-small cell lung cancer and recurrent ovarian cancer. It remains an investigational drug.
Ombrabulin has been studied in four completed clinical trials: NCT00719524, a Phase 1 trial in advanced solid tumors; NCT01263886, a Phase 2 trial in non-small cell lung cancer; NCT01293630, a Phase 1 dose-escalation trial in advanced solid tumors; and NCT01332656, a Phase 2 trial in recurrent ovarian cancer.
Yes, Ombrabulin is also known as AVE8062. Clinical trial records refer to the drug as both Ombrabulin and AVE8062, such as in the trial titled 'AVE8062 in Combination With Platinum-taxane Doublet in Advanced Solid Tumor'.