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Cost Effectiveness Of Sunitinib In Central America And Caribbean

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NCT01033981

Last updated on December 5, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Panama City, , Panama
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.
Metastatic Renal Cell Carcinoma
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

- Evidence of a personally signed (or legally acceptable representative) and dated
informed consent document indicating that the subject (or a legally acceptable
representative) has been informed of all pertinent aspects of the study.

- Adult (18 years old or older) men and women with confirmed diagnosis of mRCC treated
with Sutent, IFN-α or Bevacizumab + IFN ; on the selected institutions.

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

- Adult men or women with RCCm treated with any other medication that is not Sutent,
IFN-? or Bevacizumab + IFN.

- Adult men or women with mRCC with palliative care.

- Adult men or women with RCC without metastasis.

NCT01033981
Pfizer
Terminated
Cost Effectiveness Of Sunitinib In Central America And Caribbean

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Cost Effectiveness Of Sunitinib In Central America And Caribbean
Cost Effectiveness Of Sunitinib Vs IFN-Alfa Or Bevacizumab + IFN-Alfa As First-Line Treatment In MRCC In Central America And The Caribbean
Primary Hypothesis: The therapy with Sunitinib represents better cost-effectiveness than IFN-? in first-line treatment for metastatic Renal Cell Carcinoma (mRCC) in Central America and Caribbean countries
This study was terminated on 03Feb2011 due to the fact that the anticipated number of patients expected was not reached. The date of cessation of the drug was January 27, 2011. There was no intervention in the treatment or administration of the drug; the study only observed the treatment and collected data. As the study was dependent on the arrival of new patients with metastatic renal cancer, which was of a very low incidence, the study was terminated. Efficacy, adverse events or other safety issues were not factors in terminating the study. Lack of patients was the only reason.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Adult men and women with mRCC will be evaluated for entering the study. The decision to use Sunitinib, IFN-? or Bevacizumab + IFN must be a joint decision made by the subject and the investigator. The investigator must discuss product information with the subject as per usual practice.
Metastatic Renal Cell Carcinoma
Drug: Sunitinib
Treatment for mRCC as indication approved and physician criterium
Central America and Caribbean
Dominican Republic, Guatemala, Panama, Costa Rica, Honduras, Trinidad & Tobago
Intervention: Drug: Sunitinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
February 2011
February 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Evidence of a personally signed (or legally acceptable representative) and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
  • Adult (18 years old or older) men and women with confirmed diagnosis of mRCC treated with Sutent, IFN-? or Bevacizumab + IFN ; on the selected institutions.

Exclusion Criteria:

  • Adult men or women with RCCm treated with any other medication that is not Sutent, IFN-? or Bevacizumab + IFN.
  • Adult men or women with mRCC with palliative care.
  • Adult men or women with RCC without metastasis.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Panama
Dominican Republic,   Honduras
 
NCT01033981
A6181189
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2012

FOR MORE INFORMATION

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

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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