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COMET-1:

A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) Versus Prednisone in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Who Have Received Prior Docetaxel and Prior Abiraterone or MDV3100

This study will evaluate the effect of cabozantinib compared to prednisone on overall survival (OS) in 960 (N=960) men with previously treated mCRPC with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.

 

Primary Endpoint

  • Overall survival (OS) – determine whether cabozantinib improves survival in men in comparison to prednisone

Secondary Endpoint

  • Bone scan response at 12 weeks after start of therapy – as assessed by an independent review facility – determine whether there is a higher rate of improvement in bone scans with cabozantinib compared to placebo

COMET-1 Study Design

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Key Eligibility Criteria

  • Diagnosis of mCRPC
  • Presence of bone metastases
  • Prior treatment with docetaxel (also known as Taxotere®)
  • Prior treatment with abiraterone (also known as Zytiga®) or MDV3100 (also known as enzalutamide or Xtandi®)
  • No limit to the number of prior therapies

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Study Locations

CONTACT Exelixis® Clinical Trials

1-855-85-COMET

Frequently
Asked Questions

Learn about participation in clinical trials and other frequently asked questions (FAQs) by visiting the FAQ page.

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COMMON
TERMS

For information about common terms you may find when reading about clinical trials, visit the Common Terms page.

VIEW COMMON TERMS

About
Cabozantinib

Discover how investigators think cabozantinib works in the body by visiting the About Cabozantinib page.

Read about Cabozantinib
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