Phase Ib With Expansion of Patients at the MTD Study of Olaparib Plus Weekly (Metronomic) Carboplatin and Paclitaxel in Relapsed Ovarian Cancer Patients

Trial ID #	NCT01650376
Phase	1b
Drug Class	DNA Damage Repair Pathway Inhibitors: PARP
Drug Name	Olaparib
Alternate Drug Names	AZD2281, Lynparza
Drugs in Trial	Carboplatin, Paclitaxel, Olaparib
Eligible Participant	Recurrent ovarian cancer
Patients Enrolled	Phase Ib: 14; Expansion: 40; median 3 prior therapies
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, PFS, OS, RP2D, evaluated per RECIST
Efficacy	RP2D: 150 mg olaparib (tablet) BID, metronomic carboPt AUC2 and paclitaxel 60 mg/m2 ORR: 54% (13CR, 16PR, n=54) Exploratory analysis, BRCA status: BRCA MUT (n=23) vs BRCA WT (n=24): PFS: 12.1 vs 4.8 months (p=0.0001) OS: 24.1 vs 10.4 months (p=0.02)
Clinically Significant Adverse Events	Serious AE: Grade 3-4 AE: 78%
Conclusion	Olaparib can be safely administered with metronomic carboplatin and paclitaxel in recurrent ovarian cancer, but BRCA MUT patients experience most benefit
Reference	Rivkin SE et al., Phase Ib with expansion study of olaparib plus weekly (Metronomic) carboplatin and paclitaxel in relapsed ovarian cancer patients. Int J of Gynecol Cancer (2019) 29(2): 325-333 https://www.ncbi.nlm.nih.gov/pubmed/30700568