An Open-Label Phase I/II Study of GSK2110183 in Combination With Carboplatin and Paclitaxel in Subjects With Platinum-Resistant Ovarian Cancer

Trial ID #	NCT01653912
Phase	I/II
Drug Class	Signaling Pathway Inhibitors: PI3K-AKT-mTOR/AKT
Drug Name	Afuresertib
Alternate Drug Names	GSK2110183
Drugs in Trial	Afuresertib, Carboplatin, Paclitaxel
Eligible Participant	Platinum resistant ovarian cancer
Patients Enrolled	59 [escalation: 29; expansion: 30; median 3.8 prior therapies (1-10)]
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, PFS, evaluated per RECIST
Efficacy	ORR: 32.1% (2CR, 7PR, n=28) DCR: 71.4% (2CR, 7PR, 11SD, n=28) PFS: 7.1 months
Clinically Significant Adverse Events	Serious AE: Grade 3-4 AE: diarrhea (20%), rash (17%), fatigue (13%), vomiting (10%), anemia (10%)
Conclusion	Afuresertib mediated AKT kinase inhibition in combination with carboplatin+paclitaxel demonstrates promising efficacy in platinum resistant ovarian cancer
Reference	Blagden SP et al. Phase IB Dose Escalation and Expansion Study of AKT Inhibitor Afuresertib with Carboplatin and Paclitaxel in Recurrent Platinum-resistant Ovarian Cancer. Clin Cancer Res (2019) 25(5):1472-1478 https://pubmed.ncbi.nlm.nih.gov/30563934/