Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Larotaxel · 7 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 |
| 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 \...
Larotaxel is an investigational small molecule oncology drug being studied for breast cancer, including advanced and metastatic breast cancer, as well as pancreatic neoplasms and urinary bladder neoplasms. It has been evaluated in clinical trials for these indications, though it remains in clinical development and is not approved.
Larotaxel is a taxane, a class of chemotherapy agents that work by stabilizing microtubules and disrupting cell division. It is being studied in combination with other agents such as capecitabine and trastuzumab for the treatment of breast cancer and other solid tumors.
Larotaxel is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi has sponsored clinical trials of Larotaxel in various oncology indications.
Larotaxel has completed Phase 3 clinical trials, including a study in urothelial tract or bladder cancer. However, it is still considered investigational and has not been approved by regulatory authorities. Earlier Phase 1 and Phase 2 trials have also been completed.
Larotaxel has been studied in several completed trials, including NCT00327743 (Phase 1, with capecitabine in metastatic breast cancer), NCT00386685 (Phase 2, with trastuzumab in metastatic breast cancer), NCT00485979 (Phase 2, with or without trastuzumab in breast cancer), and NCT00625664 (Phase 3, with cisplatin in bladder cancer).
Yes, Larotaxel is also known as XRP9881. In clinical trial NCT00386685, the drug is referred to as XRP9881 in combination with trastuzumab for metastatic breast cancer. This alternative name may appear in research literature and trial registries.