TKI258 in patients with advanced and/or metastatic endometrial cancer

• Research type

  Research Study

• Full title

  A phase II, open-label, single-arm, non-randomized, multi-center study to evaluate the efficacy of oral TKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer.

• IRAS ID

  99669

• Contact name

  Rebecca Kristeleit

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-000266-35

• ISRCTN Number

  ISRCTN

• Research summary

  This study is a phase II, open-label, single-arm, non-randomised, multi-center study to evaluate the efficacy of oral TKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer. This study will enroll 80 adult patients with either FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer, who have progressed after 1 prior line of therapy (including at least 1 cytotoxic agent) for advanced and/or metastatic disease.

• REC name

  London - Central Research Ethics Committee

• REC reference

  12/LO/0629

• Date of REC Opinion

  2 May 2012

• REC opinion

  Favourable Opinion