A Phase III Study to Evaluate the Efficacy and Safety of Pazopanib Monotherapy Versus Placebo in Women Who Have Not Progressed After First Line Chemotherapy for Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Trial ID #	NCT00866697; AGO-OVAR16
Phase	III
Drug Class	Angiogenesis Inhibitors: Multi-targeted RTK
Drug Name	Pazopanib
Alternate Drug Names	Votrient
Drugs in Trial	Pazopanib
Eligible Participant	Stage II to IV disease with no evidence of progression after surgery and five or more cycles of platinum-taxane chemotherapy
Patients Enrolled	940
Therapy Setting	Maintenance
Study Design	Double Blind, Randomized
Endpoints	PFS, OS, evaluated per RECIST
Efficacy	Paz maint vs Placebo: PFS: 17.9 vs 12.3 months, HR: 0.77 (0.64–0.91, p=0.0021) OS: 59.1 vs 64.0 months, HR: 0.96 (0.81–1.15, NS)
Clinically Significant Adverse Events	Paz vs Placebo: Serious AE: fatal SAE: 3 pts vs 1 pt Grade 3-4 AE: hypertension (30.8 vs 5.6%), neutropenia (9.9 vs 1.5%), liver-related toxicity (9.4 vs 0.7%), diarrhea (8.2 vs 1.1%), fatigue (2.7 vs 0.2%)
Conclusion	Improved PFS, no OS difference with pazopanib maintenance
Reference	Du Bois A et al. Incorporation of Pazopanib in Maintenance Therapy of Ovarian Cancer. J Clin Oncol (2014) 32(30):3374-82 https://www.ncbi.nlm.nih.gov/pubmed/25225436 Vergote I et al. Overall survival results of AGO-OVAR16: A phase 3 study of maintenance pazopanib versus placebo in women who have not progressed after first-line chemotherapy for advanced ovarian cancer. Gynecol Oncol (2019) 155(2):186-191 https://www.ncbi.nlm.nih.gov/pubmed/31519320