309: XL184 vs placebo in subjects with hepatocellular carcinoma

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects with Hepatocellular Carcinoma Who Have Received Prior Sorafenib

• IRAS ID

  129331

• Contact name

  Tim Meyer

• Contact email

  t.meyer@ucl.ac.uk

• Sponsor organisation

  Exelixis, Inc.

• Eudract number

  2013-001001-91

• Clinicaltrials.gov Identifier

  113,446, IND

• Research summary

  This is a phase 3 multicentre, randomised, double-blind controlled study funded by Exelixis, Inc.

  The purpose of this study is to find out the effect of cabozantinib compared with placebo in overall survival in subjects with advanced hepatocellular carcinoma previously treated with sorafenib.

  Approximately 760 subjects will be included in this study worldwide with approximately 50 participants expected to be recruited in the UK. The duration of study participation is expected to be about 12 months. Survival will be followed until the trial is over.

  Pre-Treatment Period:
  Potential participants will be screened to determine if they meet the required eligibility criteria.

  Treatment Period:
  Participants who meet all study eligibility will be randomly assigned in a 2:1 fashion to the following treatment arms:
  • Cabozantinib arm: Oral cabozantinib (60 mg) once daily
  • Placebo arm: Oral matching placebo once daily

  Participants will receive study treatment as long as they continue to experience clinical benefit in the opinion of the investigator or until unacceptable toxicity, the need for subsequent systemic anticancer treatment. Subjects on both arms will be treated with best supportive care.

  Post Treatment Period:
  The final safety assessment will occur at the post-treatment follow-up visit 30 days after study treatment discontinuation unless a Grade 3/4 AE or SAE is determined to be ongoing.

  Radiographic tumour assessments and quality of life assessments will continue regardless of whether study treatment is given, reduced, held or discontinued, until either 8 weeks after radiographic progression or the date of the
  decision to permanently discontinue study treatment. Participants will be contacted every 8 weeks to assess survival and to document any anticancer therapy received.

  This study involves procedures including: Physical examination, vital signs, ECGs, blood and urine tests, health questionnaires and CT/MRI and bone scans.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  13/LO/1020

• Date of REC Opinion

  3 Oct 2013

• REC opinion

  Further Information Favourable Opinion