West Cancer Center

RENAL: Metastatic; >/=2nd line; "METEOR"

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

Title

Exelixis SL184-308

Study 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

Site Link

NCT01865747

Malignancy

Renal Cell, Kidney Cancer, RCC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

Investigational Agent

cabozantinib (XL184)

Drug Class

MET and VEGFR dual antagonist TKI

Brad Somer, MD

Sponsor

Exelixis

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT01865747

Key Eligibility Criteria Details

No prior everolimus or mTOR inhibitor
At least one prior VEGF TKI_
Clear cell component to RCC
Measurable disease
No known brain mets
No therapeutic anticoagulation
No chronic steroid use

Objective

Primary- PFS: Secondary- OS, ORR

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Clear cell component

Dosing Frequency

Cabozantinib 1 tab daily

Control Agents

Everolimus 1 tab daily

Study Protocol

Randomized

Yes