This trial is active, not recruiting.

Condition renal cell carcinoma
Treatments cabozantinib tablets, everolimus (afinitor) tablets
Phase phase 3
Targets mTOR, AXL, c-MET, FLT-3, KIT, RET, TRKB, VEGF, TIE2, FKBP-12
Sponsor Exelixis
Start date June 2013
End date May 2015
Trial size 650 participants
Trial identifier NCT01865747, XL184-308


The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) 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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Cabozantinib (XL184) 60 mg tablet once daily.
cabozantinib tablets XL184
(Active Comparator)
Everolimus (Afinitor) 10 mg tablet once daily.
everolimus (afinitor) tablets

Primary Outcomes

Progression-free survival (PFS)
time frame: up to 17 months

Secondary Outcomes

Overall Survival (OS)
time frame: up to 36 months
Objective Response Rate (ORR)
time frame: up to 17 months

Eligibility Criteria

Male or female participants at least 18 years old.

Select Inclusion Criteria: 1. Documented histological or cytological diagnosis of renal cell cancer with a clear-cell component. 2. Measurable disease as determined by the investigator. 3. Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib). 4. Recovery from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy. 5. Adequate organ and marrow function. 6. Sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment. 7. Female subjects of childbearing potential must not be pregnant at screening. Select Exclusion Criteria: 1. Prior treatment with everolimus, or any other specific or selective TORC1/PI3K/AKT inhibitor (eg, temsirolimus), or cabozantinib. 2. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization. 3. Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before randomization. 4. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization. Systemic treatment with radionuclides within 6 weeks before randomization. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible. 5. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization. 6. Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors. 7. Chronic treatment with corticosteroids or other immunosuppressive agents. 8. Serious illness other than cancer. 9. Major surgery within 3 months before randomization. Complete wound healing from major surgery must have occurred 1 month before randomization and from minor surgery at least 10 days before randomization. 10. Pregnant or lactating females. 11. Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low grade tumors.

Additional Information

Official 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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Exelixis.