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 APR-246
Alternate Drug Names PRIMA-1MET, p53 activator APR-246, PRIMA-1 analogue APR-246
Drugs in Trial APR-246, Carboplatin, Liposomal doxorubicin
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)
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%)

Conclusion

Encouraging activity in TP53-mutated platinum-sensitive and partially platinum-sensitive patients

Reference

Poster
http://www.poster-submission.com/esmo2016/visitors/eposter/31656