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Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer

Last updated on December 8, 2019

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Study Location
East Valley Hematology and Oncology Medical Group
Burbank, California, 91505 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically or cytologically confirmed renal cell cancer with a component of clear
cell subtype, with metastasis

- Evidence of measurable disease

- Must have failed one prior systemic first-line regimen for metastatic renal cell
cancer

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prior treatment for metastatic renal cell cancer with more that one systemic first
line therapy

- Major surgery less than 4 weeks or radiation less than 2 weeks of starting study drug

NCT00678392
Pfizer
Completed
Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer

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Descriptive Information
Brief Title  ICMJE Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer
Official Title  ICMJE AXITINIB (AG-013736) AS SECOND LINE THERAPY FOR METASTATIC RENAL CELL CANCER: AXIS TRIAL
Brief Summary The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Neoplasms
Intervention  ICMJE
  • Drug: Axitinib (AG-013736)
    axitinib will be given at a starting dose of 5 mg twice daily [BID] with continuous dosing
  • Drug: Sorafenib
    sorafenib will be given at a dose of 400 mg twice daily [BID] with continuous dosing
Study Arms  ICMJE
  • Experimental: Axitinib
    Intervention: Drug: Axitinib (AG-013736)
  • Active Comparator: Sorafenib
    Intervention: Drug: Sorafenib
Publications *


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2011)
723
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2008)
540
Actual Study Completion Date  ICMJE February 25, 2016
Actual Primary Completion Date August 31, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed renal cell cancer with a component of clear cell subtype, with metastasis
  • Evidence of measurable disease
  • Must have failed one prior systemic first-line regimen for metastatic renal cell cancer

Exclusion Criteria:

  • Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy
  • Major surgery less than 4 weeks or radiation less than 2 weeks of starting study drug
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Brazil,   Canada,   China,   France,   Germany,   Greece,   India,   Ireland,   Italy,   Japan,   Korea, Republic of,   Poland,   Russian Federation,   Singapore,   Slovakia,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT00678392
Other Study ID Numbers  ICMJE A4061032
AXIS TRIAL
2008-001451-21 ( EudraCT Number )
AXIS ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

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