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

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