Exelixis Clinical Trials

Exelixis is currently enrolling patients in our two cabozantinib phase 3 prostate cancer trials, COMET-1 and COMET-2. We are also continuing to follow patients enrolled in our phase 2 Randomized Discontinuation Trial (RDT), which is evaluating cabozantinib in a variety of cancer indications, and in a phase 1B study that is evaluating potential interactions between cabozantinib and other drugs in patients with renal cell carcinoma or differentiated thyroid cancer.

Status Tumor Types Covered Trial Description Phase Trial Information1
Active, enrollment completed Castration-Resistant Prostate Cancer Efficacy of cabozantinib (XL184) versus prednisone in castration-resistant prostate cancer (COMET-1):
evaluation of overall survival.
Phase 3 NCT01605227
Recruiting Castration-Resistant Prostate Cancer Efficacy of cabozantinib (XL184) versus mitoxantrone plus prednisone in castration-resistant prostate cancer (COMET-2): evaluation of pain response. Phase 3 NCT01522443
Recruiting Metastatic Renal Cell Carcinoma A Study of Cabozantinib (XL184) vs Everolimus in Subjects with Metastatic Renal Cell Carcinoma (METEOR). Phase 3 NCT01865747
Recruiting Hepatocellular Carcinoma A Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib (CELESTIAL) Phase 3 NCT01908426
Approved for marketing Medullary Thyroid Cancer Expanded Access Study of Cabozantinib (XL184) in Medullary Thyroid Cancer Expanded Access NCT01683110
Not yet recruiting Medullary Thyroid Cancer A Study of Two Different Doses of Cabozantinib (XL184) in Progressive, Metastatic Medullary Thyroid Cancer Phase 4 NCT01896479
Active, enrollment completed Medullary Thyroid Cancer Efficacy of cabozantinib (XL184) in Advanced Medullary Thyroid Cancer (EXAM) Phase 3 NCT00704730
Recruiting Solid Tumors
Dose-Finding Study of Cabozantinib (XL184) in Japanese Subjects With Advanced Cancer Phase 1 NCT01553656
Recruiting Healthy Hepatic Impairment Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects Phase 1 NCT01493869
Recruiting Healthy Renal Impairment A Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal Function Phase 1 NCT01761773
Active, enrollment completed Breast Cancer
Gastric/GE Junctional Cancer
Hepatocellular Carcinoma
Castration-Resistant Prostate Cancer
Non-small Cell Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Small Cell Lung Cancer
Randomized Discontinuation Trial (RDT)
Study of cabozantinib in Adults With Advanced Malignancies
Phase 2 NCT00940225
Active, enrollment completed Glioblastoma Multiforme Study of XL184 (Cabozantinib) in Adults With Glioblastoma Multiforme Phase 2 NCT00704288
Active, enrollment completed Astrocytic Tumors Study of Multiple Doses and Regimens of XL184 (Cabozantinib) in Subjects With Grade IV Astrocytic Tumors in First or Second Relapse Phase 2 NCT01068782
Active, enrollment completed Glioblastoma
Giant Cell Glioblastoma
Safety Study of XL184 (Cabozantinib) in Combination With Temozolomide and Radiation Therapy in the Initial Treatment of Adults With Glioblastoma Phase 1 NCT00960492


For more information on the Phase 3 COMET clinical trials in Castration Resistant Prostate Cancer please visit CometClinicalTrials.com.

For a detailed list of cabozantinib clinical studies posted on ClinicalTrials.gov please click HERE.  For further information regarding all clinical trials please contact Exelixis Medical Information at 1-888-EXELIXIS (1-888-393-5494) or at druginfo@exelixis.com.


  1. U.S. National Institutes of Health, ClinicalTrials.gov Web site: http://www.clinicaltrials.gov/