Cost Effectiveness Of Sunitinib In Central America And Caribbean

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NCT01033981

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Study Location
Pfizer Investigational Site
Panama City, , , Panama
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Contact
1-800-718-1021
[email protected]
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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-α or Bevacizumab + IFN.


- Adult men or women with mRCC with palliative care.


- Adult men or women with RCC without metastasis.

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Advanced Information
Descriptive Information
Brief Title Cost Effectiveness Of Sunitinib In Central America And Caribbean
Official Title Cost Effectiveness Of Sunitinib Vs IFN-Alfa Or Bevacizumab + IFN-Alfa As First-Line Treatment In MRCC In Central America And The Caribbean
Brief Summary 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
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition Metastatic Renal Cell Carcinoma
Intervention Drug: Sunitinib
Treatment for mRCC as indication approved and physician criterium
Study Groups/Cohorts Central America and Caribbean
Dominican Republic, Guatemala, Panama, Costa Rica, Honduras, Trinidad & Tobago
Intervention: Drug: Sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: August 19, 2011)		4
Original Estimated Enrollment
 (submitted: December 15, 2009)		12
Actual Study Completion Date February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Panama
Removed Location Countries Dominican Republic,   Honduras
 
Administrative Information
NCT Number NCT01033981
Other Study ID Numbers A6181189
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2012