Clinical Trial: Dovitinib for Gastric Cancer With FGFR2 Amplification

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II Trial of Dovitinib Monotherapy as Salvage Treatment in Patients With Metastatic or Unresectable Gastric Cancer Harboring FGFR2(Fibroblast Growth Factor Receptor 2

Brief Summary: This is a single-center, prospective, single-arm, open-label phase II study

Detailed Summary: In this study, we will evaluate the efficacy and safety of TKI258(Dovitinib) monotherapy as a salvage chemotherapy after failure of standard first or second-line chemotherapy in metastatic or unresectable gastric cancer harboring FGFR2 amplification.
Sponsor: Asan Medical Center

Current Primary Outcome:

• response rate [ Time Frame: 1year ]
  To evaluate with abdominal and pelvic dynamic CT scan every 6 weeks using RECIST version 1.1
• Progression-free survival [ Time Frame: From date of enrollment to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years ]
  To evaluate progression-free survival (PFS) with TKI258(Dovitinib) administered orally at 500 mg/day on a 5 days on/2 days off dosing schedule to adult patients > 18 years with evaluable metastatic or unresectable gastric cancer harboring FGFR2 amplification (copy number > 3, identified by real time PCR using TaqMan probe) who failed one or two lines of chemotherapy in palliative setting.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Number of Adverse Events [ Time Frame: 1year ]
  Monitoring for safety and toxicity will be performed every cycle (3 weeks) of chemotherapy and whenever patients have problems.
• Efficacy [ Time Frame: From date of randomization to death from any cause, assessed up to 2 years ]
  To correlate concentrations of circulating growth factors, soluble receptors with efficacy (response rate, progression free survival, and overall survival) of TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule.
• FGFR2 copy number [ Time Frame: 1year ]
  To compare FGFR2 copy number determined by FISH(fluorescence in situ hybridization) with FGFR2 copy number identified by real time PCR using TaqMan Probe.

Original Secondary Outcome:

• Number of Adverse Events [ Time Frame: 1year ]
  Monitoring for safety and toxicity will be performed every cycle (3 weeks) of chemotherapy and whenever patients have problems.
• Efficacy [ Time Frame: From date of randomization to death from any cause, assessed up to 2 years ]
  To correlate concentrations of circulating growth factors, soluble receptors with efficacy (response rate, progression free survival, and overall servival) of TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule.
• FGFR2 copy number [ Time Frame: 1year ]
  To compare FGFR2 copy number determined by FISH(fluorescence in situ hybridization) with FGFR2 copy number identified by real time PCR using TaqMan Probe.

Dates:
Date Received: October 22, 2012
Date Started: October 2012
Date Completion: March 2017
Last Updated: July 1, 2016
Last Verified: July 2016