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