OBJECTIVES: Following failure of a platinum-antifolate combination regimen, 
there is no standard therapy for advanced malignant pleural mesothelioma (MPM). 
The fibroblast growth factor receptor (FGFR) signaling pathways may be a 
relevant target in MPM. Dovitinib inhibits multiple tyrosine receptor kinases, 
predominantly the vascular endothelial growth factor receptors (VEGFR), but also 
FGFRs, and could be active in MPM.
METHODS: This open-label multicentre phase II trial [NCT01769547] enrolled fit, 
consenting adult patients with advanced MPM who had previously received 
platinum-antifolate combination chemotherapy and up to one additional line of 
systemic therapy. Dovitinib was administered orally at 500mg/day for 5days on, 
2days off, in 28-day cycles. Response was assessed every 2 cycles using RECIST 
1.1 criteria modified for MPM. Correlative studies included FGFR-1 amplification 
on archival tumour and serum samples for circulating angiogenesis factors. The 
primary end-point was the proportion of patients progression-free at 3 months 
(PF3) using a two-stage design.
RESULTS: 12 patients (10 males, median age 67) were enrolled. The median number 
of cycles administered was 2.5 (range 1-8). One unconfirmed partial response was 
observed. PF3 was 50% (95% confidence interval 28.4% to 88.0%); although the 
criterion for proceeding to stage II accrual was met, the trial was halted due 
to a combination of minimal activity with several early progression events and 
poor tolerability in this patient population. One of 12 tumour specimens had low 
amplification of FGFR-1.
CONCLUSIONS: Dovitinib has minimal activity in previously-treated MPM. The role 
of the FGFR pathway in MPM remains unclear.