Trial ID # | NCT02193633 |
Phase | I |
Drug Class | Signaling Pathway Inhibitors: PI3K-AKT-mTOR/TORC1/2 |
Drug Name | Vistusertib |
Alternate Drug Names | AZD2014 |
Drugs in Trial | Paclitaxel, Vistusertib |
Eligible Participant | Advanced solid tumors |
Patients Enrolled | 70 (Expansion: 25; median 3 prior therapies) |
Therapy Setting | Recurrence |
Study Design | Open-Label, Non-randomized |
Endpoints | ORR, PFS, RP2D, evaluated per RECIST and CA125 |
Efficacy | RP2D: 80 mg/m2/week Pac and 50 mg bid 3/7days Vis; 6/7 weeks Expansion cohort analysis (40% Pt-S/Part-Pt-S, 60% Pt-R/Pt-Rf): |
Clinically Significant Adverse Events | Dose Limiting Toxicities: fatigue, mucositis |
Conclusion | Promising drug combination with anti-tumor activity |
Reference | Basu B et al. Vistusertib (dual m-TORC1/2 inhibitor) in combination with paclitaxel in patients with high grade serous ovarian and squamous non-small cell lung cancer. Ann Oncol (2018) 29(9):1918-1925 |