XL184-307: Phase 3 study of XL184 vs Prednisone in mCRPC patients

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs. Prednisone in Metastatic Castration-resistant Prostate Cancer Patients who have Received Prior Docetaxel and Prior Abiraterone or MDV3100

• IRAS ID

  107226

• Contact name

  Johan De Bono

• Sponsor organisation

  Exelixis, Inc.

• Eudract number

  2012-001834-33

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT01605227

• Research summary

  This is a phase 3 multicenter, randomised, double-blind controlled study funded by Exelixis, Inc. The purpose of this study is to find out if cabozantinib is effective in prolonging survival in men with castration resistant prostate cancer compared to prednisone/prednisolone in subjects who have bone metastases and who have progressed on docetaxel and abiraterone or MDV3100. This study will also examine if cabozantinib has a positive effect on bone metastases. Approximately 960 subjects will be included in this study worldwide with approximately 160 participants expected to be recruited in the UK. The duration of study treatment is expected to be about 7 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 cabozantinib and prednisone/prednisolone treatment arms. Based on treatment assignment, subjects will receive one of the following regimens: ?½ Cabozantinib arm: Oral cabozantinib (60 mg) once daily plus oral prednisone/prednisolone-matched placebo twice-daily. ?½ Prednisone arm: Oral prednisone/prednisolone (5 mg) twice daily plus oral cabozantinib-matched 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 anti-cancer 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. Participants will be contacted every 6 weeks to assess survival and to document any anti-cancer 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 - Riverside Research Ethics Committee

• REC reference

  12/LO/1156

• Date of REC Opinion

  25 Sep 2012

• REC opinion

  Further Information Favourable Opinion