A Phase 2 Trial of Letrozole and Everolimus in Relapsed Hormone Receptor Positive Ovarian, Fallopian Tube or Primary Peritoneal Carcinomas

Trial ID #	NCT02283658
Phase	II
Drug Class	Signaling Pathway Inhibitors: PI3K-AKT-mTOR/mTOR
Drug Name	Everolimus
Alternate Drug Names	Afinitor, Certican, RAD001, Zortress
Drugs in Trial	Everolimus, Letrozole
Eligible Participant	Estrogen-Receptor (ER)+ recurrent ovarian cancer
Patients Enrolled	19
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	PFS, OS, evaluated per RECIST
Biomarkers	ER protein
Efficacy	PFS: 3.9 months OS: 13.0 months
Clinically Significant Adverse Events	Serious AE: none Grade 3-4 AE: any (63%), abdominal pain (16%), small intestinal obstruction (16%), anemia (16%), oral mucositis (11%), neutropenia (11%), lymphopenia (11%)
Conclusion	Promising results in ER-positive ovarian cancer
Reference	Colon-Otero G et al. Phase 2 trial of everolimus and letrozole in relapsed estrogen receptor-positive high-grade ovarian cancers. Gynecol Oncol (2017) 146(1):64-68 https://www.ncbi.nlm.nih.gov/pubmed/28461031