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Cost Effectiveness Of Sunitinib In Central America And Caribbean

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Pfizer

Status

Terminated

Conditions

Metastatic Renal Cell Carcinoma

Treatments

Drug: Sunitinib

Study type

Observational

Funder types

Industry

Identifiers

NCT01033981
A6181189

Details and patient eligibility

About

Primary Hypothesis: The therapy with Sunitinib represents better cost-effectiveness than IFN-α in first-line treatment for metastatic Renal Cell Carcinoma (mRCC) in Central America and Caribbean countries

Full 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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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-α 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-α or Bevacizumab + IFN.
  • Adult men or women with mRCC with palliative care.
  • Adult men or women with RCC without metastasis.

Trial design

4 participants in 1 patient group

Central America and Caribbean
Description:
Dominican Republic, Guatemala, Panama, Costa Rica, Honduras, Trinidad \& Tobago
Treatment:
Drug: Sunitinib

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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