Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DOCETAXEL XRP6976 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Docetaxel, Cisplatin | EXPERIMENTAL | Induction:One-hour intravenous infusion of docetaxel at 75 mg/m2 followed by a 30 minute intravenous infusion of cisplatin at 75 mg/m2. All patients to be pre-medicated with oral dexamethasone at 8 mg twice daily for 3 days, commencing one day before docetaxel infusion. All patients will be premedicated with intravenous dexamethasone 20 mg to be administered before cisplatin infusion. Docetaxel and cisplatin treatments to be repeated every 21 days for three cycles. Chemoradiotherapy (CRT): Cisplatin to be administered by 30 minutes intravenous infusion at a dose of 30 mg/m2 weekly starting concomitantly with conventional radiotherapy for a period of 6 weeks. Intravenous cisplatin to be continued for four weeks. Radiotherapy: Gross disease dose will be 60 Gy/30 fractions and sub clinical dose 45-50 Gy/30 fractions. |
| Name | Type | Description |
|---|---|---|
| Cisplatin | DRUG | Pharmaceutical form:solution Route of administration: intravenous |
| DOCETAXEL XRP6976 | DRUG | Pharmaceutical form:solution Route of administration: intravenous |
| Dexamethasone | DRUG | Pharmaceutical form:tablet Route of administration: oral |
Inclusion criteria : * Histologically confirmed, unresectable locally advanced squamous cell carcinoma of head and neck of oral cavity in stage III-IV without evidence of distant metastases. * No prior chemotherapy or radiation therapy. * Having at least one measurable lesion in one dimension. * Ag...
DOCETAXEL XRP6976 is being studied for squamous cell carcinoma of the head and neck. Specifically, it has been evaluated in unresectable locally advanced disease. It is an oncology asset developed by Sanofi and is not yet approved for this indication.
DOCETAXEL XRP6976 targets tubulin proteins, including TUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, and TUBA1A. It acts as an inhibitor of these targets. By binding tubulin, it interferes with microtubule dynamics, which disrupts cell division in cancer cells.
DOCETAXEL XRP6976 is being developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program for this small molecule oncology candidate.
DOCETAXEL XRP6976 is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 2 trial has been completed, and no active trials are currently listed.
DOCETAXEL XRP6976 has been studied in one completed Phase 2 trial, NCT02061631. The trial evaluated response to therapy with docetaxel and cisplatin in unresectable locally advanced squamous cell carcinoma of head and neck. It enrolled 35 participants in Pakistan and was uncontrolled and non-randomized.