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 DNA Damage Repair Pathway Inhibitors: PARP
Drug Name Olaparib
Alternate Drug Names AZD2281, Lynparza
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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