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

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NCT00920816

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Study Location
Advanced Medical Specialties
Miami, Florida, 33143, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

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

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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.

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  157. Virginia Beach, Virginia
  158. Woodbridge, Virginia
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  160. Seattle, Washington
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  164. Ballarat, Victoria
  165. East Melbourne, Victoria
  166. Heidelberg West, Victoria
  167. Heidelberg, Victoria
  168. Wien,
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  170. Rio de Janeiro, RJ
  171. Porto Alegre, RS
  172. Barretos, SP
  173. Sao Paulo, SP
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  175. Edmonton, Alberta
  176. Kelowna, British Columbia
  177. Moncton, New Brunswick
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Advanced Information
Descriptive Information
Brief Title  ICMJE Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer
Official Title  ICMJE AG-013736 (AXITINIB) FOR THE TREATMENT OF METASTATIC RENAL CELL CANCER
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
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 BID with continuous dosing
  • Drug: Sorafenib
    sorafenib will be given at a dose of 400 mg BID continuous dosing
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Axitinib (AG-013736)
  • Active Comparator: B
    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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 31, 2013)		492
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2009)		200
Estimated Study Completion Date  ICMJE January 6, 2021
Actual Primary Completion Date July 27, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 Bosnia and Herzegovina,   Bulgaria,   Chile,   China,   India,   Malaysia,   Mexico,   Philippines,   Romania,   Russian Federation,   South Africa,   Taiwan,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00920816
Other Study ID Numbers  ICMJE A4061051
2010-018585-23 ( EudraCT 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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2020

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