| Trial ID # | NCT02098343 |
| Phase | II |
| Drug Class | Cell Cycle Inhibitors: p53 |
| Drug Name | Eprenetapopt |
| Alternate Drug Names | PRIMA-1 analogue APR-246, p53 activator APR-246, PRIMA-1MET, APR-246 |
| Drugs in Trial | Carboplatin, Liposomal doxorubicin, Eprenetapopt |
| Eligible Participant | TP53-mutated HGS ovarian cancer with disease progression 6-24 months after a first or second Pt-based therapy |
| Patients Enrolled | 200 (Phase Ib: 28) |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DCR, PFS, evaluated per RECIST |
| Biomarkers | TP53 MUT |
| Efficacy | ORR: 62% (3CR, 10PR, n=21) Exploratory analysis Pt status: |
| Clinically Significant Adverse Events | Serious AE: 1 ruptured diverticulum |
| Conclusion | Encouraging activity in TP53-mutated Pt-S and partially Pt-S patients |
| Reference | Gourley C et al. PISARRO: A EUTROC phase 1b study of APR-246 in combination with carboplatin (C) and pegylated liposomal doxorubicin (PLD) in platinum sensitive relapsed high grade serous ovarian cancer (HGSOC). J Clin Oncol (2016) 34:(suppl; abstr 5571) Basu B et al. PISARRO: A EUTROC phase 1b study of APR-246 with carboplatin (C) and pegylated liposomal doxorubicin (PLD) in relapsed platinum-sensitive high grade serous ovarian cancer. Annals of Oncology (2016) 27 (6): 114-135. 10.1093/annonc/mdw368 |