| Trial ID # | NCT01363232 |
| Phase | I |
| Drug Class | Signaling Pathway Inhibitors: PI3K-AKT-mTOR/pan-PI3K |
| Drug Name | Buparlisib |
| Alternate Drug Names | BKM120, NVP-BKM120, AN2025 |
| Drugs in Trial | Binimetinib, Buparlisib |
| Eligible Participant | Advanced solid tumors with RAS or RAF alterations |
| Patients Enrolled | 89, median 3 prior therapies (1-12); 19 ovarian |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DCR, PFS, RP2D, evaluated per RECIST |
| Biomarkers | KRAS, NRAS, BRAF alterations |
| Efficacy | RP2D: 80 mg buparlisib qd+45 mg binimetinib bid ovarian patients at RP2D: |
| Clinically Significant Adverse Events | Serious AE: |
| Conclusion | Buparlisib+binimetinib shows encouraging efficacy in RAS/RAF MUT ovarian cancer patients, but with significant toxicity |
| Reference | Bardia A et al. Phase Ib Study of Combination Therapy with MEK Inhibitor Binimetinib and Phosphatidylinositol 3-Kinase Inhibitor Buparlisib in Patients with Advanced Solid Tumors with RAS/RAF Alterations. Oncologist (2020) 25(1):e160-e169 |