PF-03446962 in Relapsed or Refractory Urothelial Cancer
Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
Salvage chemotherapy for advanced urothelial cancer (UC) yields suboptimal response rates of
15-40%, a median progression-free survival of 2-4 months and a median overall survival of 6
months. A rationale for targeting angiogenesis in UC is supported by preclinical evidences
and early signals of clinical activity of anti-VEGF TKI as demonstrated by our group with the
use of pazopanib.
Despite this activity, progression inevitably occurs and mechanisms determining resistance to
conventional anti-angiogenic agents are under investigation.
PF-03446962 (Pfizer Inc) is a novel fully human monoclonal antibody (mAb) against ALK1 with
dose-dependent antiangiogenic activity as demonstrated in nonclinical studies in a chimera
mouse model bearing human tumor xenograft. The investigators suggest that PF-03446962 may
increase current results for patients with advanced urothelial cancer failing upfront
chemotherapy due to its mechanisms of action. Due to the lack of reliable and reproducible
predictors of response as well as of imaging tools to assess tumor response, the trial will
provide incorporation of 18FDG-PET/CT and contrast-enhanced ultrasound to stage and evaluate
response of urothelial cancers, together with standard imaging modalities (RECIST criteria).
Blood and tissue samples will be collected for translational purposes.
Phase:
Phase 2
Details
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano