308: Phase 3 study of XL184 vs Everolimus in subjects with RCC

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects with Metastatic Renal Cell Carcinoma that has Progressed after Prior VEGFR Tyrosine Kinase Inhibitor Therapy

• IRAS ID

  129329

• Contact name

  Thomas Powles

• Contact email

  thomas.powles@bartshealth.nhs.uk

• Sponsor organisation

  Exelixis Inc

• Eudract number

  2013-001010-14

• ISRCTN Number

  n/a

• Research summary

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

  The purpose of this study is to find out the effect of cabozantinib compared with everolimus on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor therapy.

  Approximately 650 subjects will be included in this study worldwide with approximately 50 participants expected to be recruited in the UK. The duration of study treatment is expected to be about 8 months. Survival will be followed until the trial is over.

  PreTreatmentPeriod:
  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 1:1 fashion to receive open-label treatment with either cabozantinib or everolimus as follows:
  • Cabozantinib arm: Oral cabozantinib (60 mg) once daily
  • Everolimus arm: Oral everolimus (10 mg) 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, or until any of the other reasons for treatment discontinuation listed in the protocol.

  Post Treatment Period:
  A Post Treatment Follow-Up Visit for safety follow up will occur at least 30 days after study treatment discontinuation. 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 - Brent Research Ethics Committee

• REC reference

  13/LO/1022

• Date of REC Opinion

  12 Sep 2013

• REC opinion

  Further Information Favourable Opinion