A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma (METEOR)
Verified September 2014 by Exelixis
Information provided by (Responsible Party):
First received: May 21, 2013
Last updated: September 11, 2014
Last verified: September 2014
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.
Renal Cell Carcinoma
Drug: Cabozantinib (XL184)
Drug: Everolimus (Afinitor)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
Secondary Outcome Measures:
- Overall Survival (OS) [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
OS is measured from the time of randomization until death due to any cause assessed up to 36 months.
- Objective Response Rate (ORR) [ Time Frame: up to 17 months ] [ Designated as safety issue: No ]
ORR is the proportion of subjects, assessed up to 17 months, who have measurable disease at baseline and who have complete response (CR) or partial response (PR) at data cut off.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2015 (Final data collection date for primary outcome measure)
Experimental: Cabozantinib (XL184)
Cabozantinib (XL184) administered as an oral single tablet once daily.
Drug: Cabozantinib (XL184)
Active Comparator: Everolimus (Afinitor)
Everolimus (Afinitor) administered as an oral single tablet once daily.
Drug: Everolimus (Afinitor)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Select Inclusion Criteria:
- Documented histological or cytological diagnosis of renal cell cancer with a clear-cell component.
- Measurable disease as determined by the investigator.
- Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib).
- Recovery from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
- Adequate organ and marrow function.
- 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.
- Female subjects of childbearing potential must not be pregnant at screening.
Select Exclusion Criteria:
- Prior treatment with everolimus, or any other specific or selective TORC1/PI3K/AKT inhibitor (eg, temsirolimus), or cabozantinib.
- Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization.
- Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before randomization.
- 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.
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization.
- Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors.
- Chronic treatment with corticosteroids or other immunosuppressive agents.
- Serious illness other than cancer.
- 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.
- Pregnant or lactating females.
- Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low grade tumors.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01865747
|Contact: Exelixis Clinical Trials
||1-888- EXELIXIS (888-393-5494)
|Contact: Backup or International
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 21, 2013
||September 11, 2014
||United States: Food and Drug Administration
Keywords provided by Exelixis:
renal cell cancer
vascular endothelial growth factor receptor 2 (VEGFR2)
tyrosine kinase inhibitor
hepatocyte growth factor receptor protein (MET)
von Hippel-Lindau gene
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Physiological Effects of Drugs