RANGE - Ramucirumab in Advanced Bladder Cancer (JVDC Study)

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of Ramucirumab plus Docetaxel Versus Placebo plus Docetaxel in Patients with Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or After Platinum-Based Therapy

• IRAS ID

  176881

• Contact name

  Thomas Powles

• Contact email

  thomas.powles@bartshealth.nhs.uk

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2014-003655-66

• Clinicaltrials.gov Identifier

  NCT02426125

• Duration of Study in the UK

  2 years, 8 months, 24 days

• Research summary

  Bladder cancer is the 5th most common cancer in Europe, with an estimated 151 297 new cases diagnosed in 2012 (118 365 males and 32 932 females) (GLOBOCAN 2012). Although a large number of patients have a good response to the initial treatment, 90% of patients eventually experience relapse and their cancer returns. Docetaxel is one of the medications recommended by the National Comprehensive Cancer Network for treatment of advanced or metastatic bladder cancer.

  The RANGE study is an international, randomised, double-blind, placebo-controlled trial for patients with advanced or inoperable or metastatic bladder cancer. The total trial duration is approximately 33 months, and we are planning to enrol around 524 patients.

  The RANGE study is comparing 2 treatment regimens - Ramucirumab plus Docetaxel versus placebo plus Docetaxel. Patients will be randomised 1:1 to these treatment regimens and will receive their study treatment on Day 1 of each 21-day cycle: Ramucirumab (10 mg/kg) intravenously (I.V.) plus Docetaxel (75 mg/m2) I.V. OR placebo (10 mg/kg volume equivalent) I.V. plus Docetaxel (75 mg/m2) I.V.
  
  Provided no pre-specified discontinuation criteria have been met (including radiographic documentation of disease progression, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent), treatment with Docetaxel may continue for up to six 21-day cycles (maximum of 10 cycles in total may be administered with Sponsor’s approval). Treatment with Ramucirumab or placebo (monotherapy) may continue on 21-day cycles until at least one discontinuation criterion is met. This is an outpatient study.

  The primary objective of the RANGE trial is to compare progression-free survival between the two treatment regimens (ie. Can Docetaxel - Ramucirumab combination reduce tumour’s ability to grow / spread and thus slow down disease progression?). Study assessments will include: physical examinations, questionnaire completions, blood & urine tests, ECG and radiological scans (MRI, CT,[bone scan if needed]).

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  15/SC/0306

• Date of REC Opinion

  28 May 2015

• REC opinion

  Favourable Opinion