A Phase I Multi-centre Trial of the Combination of Olaparib (PARP Inhibitor) and AZD5363 (AKT Inhibitor) in Patients With Advanced Solid Tumours

Trial ID # NCT02338622
Phase I
Drug Class Signaling Pathway Inhibitors: PI3K-AKT-mTOR/AKT
Drug Name Capivasertib
Alternate Drug Names AZD5363, Akt inhibitor AZD5363
Drugs in Trial Olaparib, Capivasertib
Eligible Participant

Recurrent ovarian cancer

Patients Enrolled

25 ovarian in dose escalation and dose expansion, median 5 prior therapies (1-12), 16 BRCA MUT

Therapy Setting


Study Design

Open-Label, Randomized


ORR, DCR, evaluated per RECIST


ORR: 24% (5PR, 1uPR - 3 Pt-S: 2BRCA MUT - 3 Pt-R: 2BRCA MUT, 1PTEN and KRAS and SMARCA4 MUT)
DCR (4 months): 45.8% (5PR, 1uPR, 5SD - 5 Pt-R: 5BRCA MUT) - 5/11 patients had prior PARPi


Capivasertib+olaparib is safe and tolerable and anti-tumor activity is observed in patients harboring tumors with BRCA MUT and BRCA WT cancers with or without somatic DDR and/or PI3K-AKT pathway alterations


Yap T et al. Phase I Trial of the PARP Inhibitor Olaparib and AKT Inhibitor Capivasertib in Patients with BRCA1/2 - and Non-BRCA1/2-Mutant Cancers. Cancer Discov (2020) 10(10):1528-1543

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