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Fixed-dose combination of capecitabine and cyclophosphamide SAR439281 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SAR439281(Cohort 1) | EXPERIMENTAL | Regimen 1: one full-dose tablet containing capecitabine and cyclophosphamide, given BID without interruption |
| SAR439281(Cohort 2) | EXPERIMENTAL | Regimen 2: two tablets containing capecitabine and cyclophosphamide, given OD without interruption |
| SAR439281(Cohort 3) | EXPERIMENTAL | Regimen 3: one tablet containing capecitabine and cyclophosphamide, given OD without interruption |
| Name | Type | Description |
|---|---|---|
| Fixed-dose combination of capecitabine and cyclophosphamide SAR439281 | DRUG | Pharmaceutical form:Tablet Route of administration: Oral |
Inclusion criteria: * Female ≥18 and ≤65 years old. * Patients with histologically or cytologically confirmed Metastatic Breast Cancer (HER2 negative, ER/PR positive or negative), who are candidates to receive capecitabine and cyclophosphamide as per Investigator's judgment, and meet either one of ...
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It is an investigational oral small molecule therapy developed by Sanofi that combines capecitabine and cyclophosphamide into a single pill. It is being studied for the treatment of metastatic breast cancer. The combination is designed to simplify administration by delivering both chemotherapeutic agents in one dosage form.
It is being developed for the treatment of metastatic breast cancer. The Phase 2 study enrolled patients with advanced breast cancer. The fixed-dose combination is intended to provide a convenient oral treatment option for this indication.
Sanofi is developing the fixed-dose combination of capecitabine and cyclophosphamide SAR439281. Sanofi trades on the New York Stock Exchange under the ticker symbol SNY. The company is responsible for the clinical development of this asset.
The fixed-dose combination of capecitabine and cyclophosphamide SAR439281 is in Phase 2 clinical development. A Phase 2 trial has been completed. It is an investigational therapy and has not been approved by regulatory authorities for any indication.
The fixed-dose combination of capecitabine and cyclophosphamide SAR439281 has been evaluated in one Phase 2 clinical trial, NCT02664103, titled "Study of Capecitabine and Cyclophosphamide Administered as a Single Pill in Patients With Advanced Breast Cancer." The trial was completed and enrolled 2 participants in India.