Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03411161 | S 81694 Plus Paclitaxel in Metastatic Breast Cancer | PHASE1 | COMPLETED | 22 | — | — | Jan 4, 2018 | Jun 8, 2020 | May 25, 2021 | 6 | Belgium, France +2 |
Safety criterion - A DLT is defined as any toxicity attributable to S81694 or the combination that occurs before the end of Cycle 1
Safety and tolerability criteria - Incidence of treatment-emergent adverse events (AEs) graded according to NCI CTCAE v4.03
Safety and tolerability criteria disease progression according to RECIST v1.1 or death due to any cause
Safety and tolerability criteria
Safety and tolerability criteria - Treatment-emergent changes in physical examinations, ECOG performance status, at periodic intervals during the study and at End of Treatment
Safety and tolerability criteria - Treatment-emergent changes in physical examinations, ECOG performance status, at periodic intervals during the study and at End of Treatment
Safety and tolerability criteria - Treatment-emergent changes in physical examinations, ECOG performance status, at periodic intervals during the study and at End of Treatment
Safety and tolerability criteria - Treatment-emergent changes in physical examinations, ECOG performance status, at periodic intervals during the study and at End of Treatment
Safety and tolerability criteria - Treatment-emergent changes in physical examinations, ECOG performance status, at periodic intervals during the study and at End of Treatment
Efficacy criterion - time from the date of first study drug intake until the date of the investigator-assessed disease progression or death due to any cause whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| Combination therapy (S81694 + paclitaxel) phase I | EXPERIMENTAL | Phase I: Single arm, non-randomized study in metastatic breast cancer patients. S81694 given intravenously every two weeks at different doses on D1 and D15 last for 28 days. The participants will also receive paclitaxel intravenously on D1, D8 and D15 last for 28 days. |
| paclitaxel phase II | ACTIVE_COMPARATOR | Phase II: Randomised phase II part , two-arm, in untreated metastatic triple negative breast cancer patients. Paclitaxel given intravenously on D1, D8, and D15 at 80 mg/m² during a 28-day cycle. |
| Combination therapy (S81694 + paclitaxel) phase II | EXPERIMENTAL | Phase II: Randomised phase II part , two-arm, in untreated metastatic triple negative breast cancer patients. S 81694 given intravenously on D1 and D15 at recommended phase 2 dose (RP2D). Paclitaxel given intravenously on D1, D8, and D15 during a 28-day cycle. |
| Name | Type | Description |
|---|---|---|
| Combination therapy (S81694 + paclitaxel) phase I | DRUG | Dose escalation S 81694 (IV); paclitaxel started at 80 mg/m²,(IV) |
| Paclitaxel | DRUG | Paclitaxel (IV) at 80 mg/m²/week |
| Combination therapy (S81694 + paclitaxel) phase II | DRUG | S 81694 (IV) at RP2D; paclitaxel (IV) at 80 mg/m²/week |
Inclusion Criteria: For Phase I : * Histologically or cytologically confirmed metastatic breast cancer, refractory to any standard therapy or for which the standard therapy is considered unsuitable; * Patient must have at least one evaluable or measurable metastatic lesion (lesions as defined by r...