Status:
COMPLETED
A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma
Lead Sponsor:
Exelixis
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 r...
Eligibility Criteria
Inclusion
- Select
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2021
Estimated Enrollment :
658 Patients enrolled
Trial Details
Trial ID
NCT01865747
Start Date
June 1 2013
End Date
January 15 2021
Last Update
April 27 2021
Active Locations (205)
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1
Birmingham, Alabama, United States
2
Anchorage, Alaska, United States, 99503
3
Gilbert, Arizona, United States, 85234
4
Scottsdale, Arizona, United States, 85259