A Phase 2 Study of AZD2171 in Patients With Recurrent Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer

Trial ID #	NCT00275028
Phase	II
Drug Class	Angiogenesis Inhibitors: VEGFR
Drug Name	Cediranib
Alternate Drug Names	Recentin, Cediranib maleate, AZD2171
Drugs in Trial	Cediranib
Eligible Participant	Recurrent measurable disease, ≤ 2 prior lines of therapy for recurrence
Patients Enrolled	46; median 2 prior therapies (1-3); 16 Pt-S, 30 Pt-R
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, PFS, OS, evaluated per RECIST or CA125
Efficacy	ORR: 17% (8PR, n=46) DCR: 30% (8PR, 6SD, n=46) PFS: 5.2 months OS: NR (median follow up 10.7 months) Exploratory analysis Pt status: Pt-S (n=16): ORR: 13% (2PR); DCR: 25% (2PR, 2SD); PFS: 5.2 months Pt-R (n=30): ORR: 20% (6PR); DCR: 33% (6PR, 4SD); PFS: 5.2 months
Clinically Significant Adverse Events	Serious AE: CNS hemorrhage, dehydration (1 patient) Grade 3-4 AE: hypertension (46%), fatigue (24%), diarrhea (13%)
Conclusion	Promising activity with significant toxicity (hypertension)
Reference	Matulonis UA et al. Cediranib, an oral inhibitor of vascular endothelial growth factor receptor kinases, is an active drug in recurrent epithelial ovarian, fallopian tube, and peritoneal cancer. J Clin Oncol (2009) 27(33):5601-6 http://www.ncbi.nlm.nih.gov/pubmed/19826113