FIESTA

• Research type

  Research Study

• Full title

  FGFR Inhibition for Epithelial Solid Tumours: a Phase Ib trial of AZD4547 in combination with gemcitabine and cisplatin

• IRAS ID

  87348

• Contact name

  John Chester

• Sponsor organisation

  University of Leeds

• Eudract number

  2011-004072-10

• ISRCTN Number

  ISRCTN44149443

• Research summary

  Transitional cell carcinoma of the bladder is sensitive to systemic chemotherapy for locally advanced or metastatic disease. Cisplatin based combination chemotherapy are standard of care for these patients and demonstrate a survival of approximately 50% compared to no chemotherapy. AZD4547 is a tyrosine kinase inhibitor with high selectivity for the FGFR family of trans-membrane receptors. Combining AZD4547 with GC may increase the sensitivity of the tumour to either gemcitabine or cisplatin. The purpose of the study is to determine if AZD4547 is safe to give in combination with gemcitabine and cisplatin, and the dose at which AZD4547 should be given. Once the dose of AZD4547 has been identified this will be taken forward to a randomised dose expansion cohort within the trial to compare AZD4547, gemcitabine and cisplatin with gemcitabine and cisplatin alone.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  12/LO/0864

• Date of REC Opinion

  12 Jun 2012

• REC opinion

  Favourable Opinion