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

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NCT00678392

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
East Valley Hematology and Oncology Medical Group
Burbank, California, 91505 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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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Pfizer Clinical Trials Contact Center

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Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer
Axitinib (Ag-013736) As Second Line Therapy For Metastatic Renal Cell Cancer: Axis Trial
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Neoplasms
  • 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
  • Experimental: Axitinib
    Intervention: Drug: Axitinib (AG-013736)
  • Active Comparator: Sorafenib
    Intervention: Drug: Sorafenib


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
723
February 2016
August 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
Netherlands
 
NCT00678392
A4061032
AXIS TRIAL
2008-001451-21 ( EudraCT Number )
AXIS ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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