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Also known as larotaxel (XRP9881), XRP9881
larotaxel · 8 trials · 8 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Larotaxel (XRP9881) | EXPERIMENTAL | - |
| 5-Fluorouracil or capecitabine | ACTIVE_COMPARATOR | Each Investigator must choose either IV 5-FU or oral capecitabine regimen before the first participant begins the study and has to consistently use the chosen regimen throughout the study for all participants treated at her/his site. |
| Arm A1 | EXPERIMENTAL | Cohort 1: Her2-ve breast cancer |
| Arm B1 | ACTIVE_COMPARATOR | Cohort 1: Her2-ve breast cancer |
| Arm A2 | EXPERIMENTAL | Cohort 2: Her2+ve breast cancer |
| Arm B2 | ACTIVE_COMPARATOR | Cohort 2: Her2+ve breast cancer |
| Larotaxel + Trastuzumab | EXPERIMENTAL | - |
| larotaxel + Capecitabine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| larotaxel (XRP9881) | DRUG | administered on day 1 as a 1-hour infusion |
| gemcitabine | DRUG | administered on day 1, 8 and 15 as a 30-minute infusion |
| cisplatin | DRUG | 1 hour infusion administered on day 1, 30 minutes after the other treatment |
| 5-Fluorouracil | DRUG | administered as IV infusion from Day 1 to Day 4 |
| Capecitabine | DRUG | administered orally from Day 1 to Day 14 q3w |
| larotaxel (RPR109881, XRP9881) | DRUG | - |
| docetaxel | DRUG | intravenous administration |
| trastuzumab | DRUG | intravenous administration |
| XRP9881 | DRUG | - |
| larotaxel | DRUG | IV infusion on Day 1 of a 21-day cycle |
Inclusion Criteria: * Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) with locally advanced (T4b) or metastatic urothelial tract or bladder cancer * ECOG Performance Status 0 or 1 * No prior palliative chemotherapy Exclusion Criteria: * (Neo)Adjuvant chemotherapy if \...
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Larotaxel is an investigational small molecule studied in oncology for advanced breast cancer, breast neoplasms, pancreatic neoplasms, and urinary bladder neoplasms. It has been evaluated in Phase 2 and Phase 3 clinical trials, including studies in metastatic breast cancer, advanced pancreatic cancer, and locally advanced or metastatic urothelial tract or bladder cancer.
Larotaxel targets tubulin proteins including TUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, and TUBA1A. It acts as a tubulin stabiliser, a mechanism that interferes with microtubule dynamics and cell division. This target class is shared with other taxane-class chemotherapy agents used in solid tumors.
Larotaxel is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the clinical trial program evaluating larotaxel across breast, pancreatic, and bladder cancer indications.
Larotaxel is in Phase 2 development overall, though individual trials have reached Phase 3. It is investigational and has not been approved by the FDA. Two completed trials enrolled 472 patients in total, and no trials are currently active.
Larotaxel has been studied in completed trials including NCT00625664, a Phase 3 trial in urothelial tract or bladder cancer; NCT00485979, a Phase 2 trial in breast cancer; NCT00417209, a Phase 3 trial in advanced pancreatic cancer; and NCT00387907, a Phase 2 trial in HER2 positive metastatic breast cancer.
Yes, larotaxel is also known as XRP9881 and RPR109881. These are alternative identifiers for the same investigational compound developed by Sanofi, so searches for XRP9881 or RPR109881 refer to larotaxel.