MITO-11: A Randomized Multicentre Phase II Trial With Pazopanib and Weekly Paclitaxel vs Weekly Paclitaxel in Platinum Resistant or Refractory Ovarian Cancer

Trial ID #	NCT01644825; MITO-11
Phase	II
Drug Class	Angiogenesis Inhibitors: Multi-targeted RTK
Drug Name	Pazopanib
Alternate Drug Names	Votrient
Drugs in Trial	Paclitaxel, Pazopanib
Eligible Participant	Platinum resistant or refractory ovarian cancer with ≤ 2 prior therapies
Patients Enrolled	74
Therapy Setting	Recurrence
Study Design	Open-Label, Randomized
Endpoints	ORR, PFS, OS, evaluated per RECIST and CA125
Efficacy	Pac+Paz vs Pac: ORR (RECIST): 56 vs 25% (p=0.008) ORR (CA125): 77 vs 35% (p=0.0012) PFS: 6.35 vs. 3.49 months, HR: 0.42 (0.25–0.69; p=0.0002) OS: 19.1 vs. 13.7 months, HR: 0.60 (0.32-1.13; p=0.056)
Clinically Significant Adverse Events	Pac+Paz vs Pac: Serious AE: ileal perforation (n=1, Pac+Paz arm) Grade 3-4 AE: any (59 vs 31%), neutropenia (30 vs 3%), fatigue (11 vs 6%), leucopenia (11 vs 3%), hypertension (8 vs 0%), raised liver enzymes (8 vs 0%), anemia (5 vs 14%)
Conclusion	Improved ORR and PFS with combination therapy
Reference	S. Pignata et al. Pazopanib plus weekly paclitaxel versus weekly paclitaxel alone for platinum-resistant or platinum-refractory advanced ovarian cancer (MITO 11): a randomised, open-label, phase 2 trial. Lancet Oncol (2016) 16(5): 561-68 http://www.ncbi.nlm.nih.gov/pubmed/25882986