A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma (METEOR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Exelixis
Sponsor:
Information provided by (Responsible Party):
Exelixis
ClinicalTrials.gov Identifier:
NCT01865747
First received: May 21, 2013
Last updated: July 8, 2014
Last verified: July 2014

May 21, 2013
July 8, 2014
June 2013
September 2015   (final data collection date for primary outcome measure)
Progression-free survival (PFS) [ Time Frame: up to 17 months ] [ Designated as safety issue: No ]
PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed for up to 17 months.
Same as current
Complete list of historical versions of study NCT01865747 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Cell Carcinoma
  • Drug: Cabozantinib (XL184)
  • Drug: Everolimus (Afinitor)
  • Experimental: Cabozantinib (XL184)
    Cabozantinib (XL184) administered as an oral single tablet once daily.
    Intervention: Drug: Cabozantinib (XL184)
  • Active Comparator: Everolimus (Afinitor)
    Everolimus (Afinitor) administered as an oral single tablet once daily.
    Intervention: Drug: Everolimus (Afinitor)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
650
August 2016
September 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Exelixis Clinical Trials 1-888- EXELIXIS (888-393-5494) druginfo@exelixis.com
Contact: Backup or International 650-837-7400
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hungary,   Ireland,   Italy,   Korea, Republic of,   Netherlands,   Poland,   Portugal,   Russian Federation,   Slovakia,   Spain,   Sweden,   Taiwan,   Turkey,   United Kingdom
 
NCT01865747
XL184-308
Yes
Exelixis
Exelixis
Not Provided
Not Provided
Exelixis
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP