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
  Purpose

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.


Condition Intervention Phase
Renal Cell Carcinoma
Drug: Cabozantinib (XL184)
Drug: Everolimus (Afinitor)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Exelixis:

Primary Outcome Measures:
  • 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.


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: 650
Study Start Date: June 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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

Contacts
Contact: Exelixis Clinical Trials 1-888- EXELIXIS (888-393-5494) druginfo@exelixis.com
Contact: Backup or International 650-837-7400

  Show 211 Study Locations
Sponsors and Collaborators
Exelixis
  More Information

No publications provided

Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT01865747     History of Changes
Other Study ID Numbers: XL184-308
Study First Received: May 21, 2013
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Exelixis:
renal cell cancer
kidney
vascular endothelial growth factor receptor 2 (VEGFR2)
tyrosine kinase inhibitor
hepatocyte growth factor receptor protein (MET)
von Hippel-Lindau gene

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 26, 2014