A phase II evaluation of @entity19977 in the treatment of recurrent or persistent XXXX : An NRG Oncology/Gynecologic Oncology Group study.

@entity1204 @entity1 @entity137 @entity7 @entity5 @entity19977 @entity4149
PURPOSE: @entity19977 is a multi- @entity4149 kinase inhibitor targeting @entity7 ( @entity7 ), platelet-derived growth factor (PDGF), and fibroblast growth factor (FGF) receptors. This phase II study was conducted to assess activity and tolerability of single-agent @entity19977 in recurrent/persistent @entity1204 . @entity1 AND METHODS: Eligible @entity1 had recurrent or persistent @entity1204 after receiving one or two prior cytotoxic regimens, measurable disease, and Gynecologic Oncology Group (GOG) performance status of  <=2 ( <=1 if two prior cytotoxic regimens given). @entity19977 30mg orally daily for a 28daycycle was administered until disease progression or prohibitive @entity137 . Microvessel density (MVD) was measured in @entity5 tissue from initial hysterectomy specimens and correlated with clinical outcome. Primary endpoints were @entity5 response and surviving progression-free for six months without subsequent therapy (6-month event-free survival [EFS]). RESULTS: Of 53 @entity1 enrolled, 48 were evaluable for @entity19977 efficacy and @entity137 . Median age was 65.5 years, 52% of @entity1 had received prior radiation, and 73% of @entity1 received only one prior chemotherapy regimen. A partial response was observed in 12.5%. Fourteen @entity1 (29%) had six-month EFS. Median progression-free survival (PFS) was 3.65 months and median overall survival (OS) 12.5 months. No grade 4 or 5 @entity137 were observed. A trend towards improved PFS was found in @entity1 whose @entity5 expressed high MVD. CONCLUSION: @entity19977 as a monotherapy treatment for recurrent or persistent @entity1204 is well tolerated and met protocol set objectives for sufficient activity to warrant further investigation. MVD may be a useful biomarker for activity.
