The BAROCCO Study (Best Approach in Recurrent-Ovarian-Cancer-with Cediranib-Olaparib): an Italian Multicenter Randomized Phase II Study of Weekly Paclitaxel vs. Cediranib-Olaparib With Continuous Schedule vs. Cediranib-Olaparib With Intermittent Schedule in Patients With Platinum Resistant High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.

Trial ID #	NCT03314740; BAROCCO
Phase	II
Drug Class	DNA Damage Repair Pathway Inhibitors: PARP
Drug Name	Olaparib
Alternate Drug Names	AZD2281, Lynparza
Drugs in Trial	Cediranib, Olaparib
Eligible Participant	Platinum resistant ovarian cancer
Patients Enrolled	123 (median Pt-free interval 1.8 months; 59% of patients had > 3 prior therapies)
Therapy Setting	Recurrence
Study Design	Open-Label, Randomized
Endpoints	PFS, evaluated per RECIST
Biomarkers	Exploratory: BRCA status
Efficacy	Ola+Ced (continuous) vs Ola+Ced (intermittent) vs Pac: PFS: 5.6 vs 3.8 vs 3.1 months, HR: 0.76 (0.50-1.14, p = 0.27); HR:1.03 (0.68-1.55, p = 0.90) Exploratory analysis: gBRCA WT (n=109): PFS: 5.8 vs 3.8 vs 2.1 months, HR: 0.63 (0.36-1.10, p = 0.10)
Clinically Significant Adverse Events	Ola+Ced (continuous) vs Ola+Ced (intermittent) vs Pac: Serious AE: 2 deaths; 1 in Ola+Ced (continous), 1 in Pac Grade 3-4 AE:
Conclusion	The combination of olaparib and cediranib is not superior to chemotherapy in terms of PFS in heavily pretreated platinum resistant ovarian cancer patients. However, this oral doublet, is active and may offer a non-chemotherapy option in this difficult to treat population
Reference	Colombo N et al. Randomized phase II trial of weekly paclitaxel vs. cediranib-olaparib (continuous or intermittent schedule) in platinum-resistant high-grade epithelial ovarian cancer. Gynecol Oncol (2022) 164(3):505-513 https://pubmed.ncbi.nlm.nih.gov/35063281/