PiSARRO: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246

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


Study Design

Open-Label, Non-randomized


ORR, DCR, PFS, evaluated per RECIST




ORR: 62% (3CR, 10PR, n=21)
DCR: 100% (3CR, 10PR, 8SD, n=21)
PFS: 10.5 months

Exploratory analysis Pt status:
Pt-S: ORR: 71% (2CR, 3PR, n=7)
Part Pt-S: ORR: 57% (1CR, 7PR, n=14)

Clinically Significant Adverse Events

Serious AE: 1 ruptured diverticulum
Grade 3-4 AE: any (75%), neutropenia (50%), infections (36%), anemia (25%), device related infection (25%), gastrointestinal disorders (18%), thrombocytopenia (14%), vomiting (11%)


Encouraging activity in TP53-mutated Pt-S and partially Pt-S patients


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

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