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Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer

Last updated on July 10, 2018

FOR MORE INFORMATION
Study Location
Advanced Medical Specialities
Miami, Florida, 33143 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 documented metastatic renal cell cancer with a component of clear cell
histology.

- Evidence of measurable disease.

- Patients with mRCC must have received no prior systemic first-line therapy or must
have progressive disease per RECIST (version 1.0) after one prior systemic first line
regimen for metastatic disease containing sunitinib, cytokine(s), or both.

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 that 4 weeks or radiation less than 2 weeks of starting study drug.

NCT00920816
Pfizer
Active, not recruiting
Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer

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Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer
Ag-013736 (Axitinib) For The Treatment Of Metastatic Renal Cell Cancer
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Neoplasms
  • Drug: Axitinib (AG-013736)
    axitinib will be given at a starting dose of 5 mg BID with continuous dosing
  • Drug: Sorafenib
    sorafenib will be given at a dose of 400 mg BID continuous dosing
  • Experimental: A
    Intervention: Drug: Axitinib (AG-013736)
  • Active Comparator: B
    Intervention: Drug: Sorafenib


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
492
November 2017
July 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically documented metastatic renal cell cancer with a component of clear cell histology.
  • Evidence of measurable disease.
  • Patients with mRCC must have received no prior systemic first-line therapy or must have progressive disease per RECIST (version 1.0) after one prior systemic first line regimen for metastatic disease containing sunitinib, cytokine(s), or both.

Exclusion Criteria:

  • Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy.
  • Major surgery less that 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
Bosnia and Herzegovina,   Bulgaria,   Chile,   China,   India,   Malaysia,   Mexico,   Philippines,   Romania,   Russian Federation,   South Africa,   Taiwan,   Ukraine,   United States
 
 
NCT00920816
A4061051
2010-018585-23 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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