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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01673737 | A Phase I/Ib Trial for the Evaluation of SAR260301 in Monotherapy or in Combination With Vemurafenib in Patients With Various Advanced Cancer | PHASE1 | COMPLETED | 75 | — | — | Aug 1, 2012 | Feb 1, 2015 | Apr 10, 2015 | 4 | United States, Canada |
| Arm | Type | Description |
|---|---|---|
| Part A Monotherapy | EXPERIMENTAL | Dose escalation of daily or twice daily SAR260301 within a 28-day cycle, followed by an expansion phase at the maximal tolerated dose |
| Part B Combination | EXPERIMENTAL | Dose escalation of twice-daily SAR260301 within a 28-day cycle and in combination with 720 or 960 mg twice daily of Vemurafenib, followed by an expansion phase at the maximal tolerated dose of SAR260301 in combination |
| Name | Type | Description |
|---|---|---|
| SAR260301 | DRUG | Pharmaceutical form: film-coated tablets Route of administration: oral |
| Vemurafenib | DRUG | Pharmaceutical form: film-coated tablets Route of administration: oral |
Inclusion criteria : * Age ≥18 years old * Locally advanced or metastatic solid tumor disease as well as lymphoma for which no alternative therapy is available (Part A) * Unresectable / metastatic BRAF-mutated melanomas, progressing on BRAF inhibitor after no more than 4 months treatment or with on...