Phase Ib/II Eribulin Mesylate Bladder Cancer

• Research type

  Research Study

• Full title

  An Open-Label, Multicenter, Randomized Phase Ib/II Study of Eribulin Mesylate Administered in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladder Cancer

• IRAS ID

  51888

• Contact name

  Stephen Nicholson

• Sponsor organisation

  Eisai Inc

• Eudract number

  2009-015915-42

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of this study is to find out the maximum tolerated dose (MTD), safety, tolerability and efficacy of eribulin mesylate administered in combination with gemcitabine plus cisplatin versus Gemcitabine plus Cisplatin alone in patients with locally advanced or metastatic bladder cancer.This study consists of 2 phases:Phase Ib:a safety run-in period with 3 ascending doses of eribulin;Phase II:a randomized 2-arm design, patients will receive either eribulin in combination with gemcitabine plus cisplatin or gemcitabine plus cisplatin alone.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  10/H0703/56

• Date of REC Opinion

  2 Aug 2010

• REC opinion

  Further Information Favourable Opinion