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Cost Effectiveness Of Sunitinib In Central America And Caribbean

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NCT01033981

Last updated on October 8, 2019
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Panama City, , Panama
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Contact
1-800-718-1021
ClinicalTrials.gov_Inquiries[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-? 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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Descriptive Information
Brief TitleCost Effectiveness Of Sunitinib In Central America And Caribbean
Official TitleCost Effectiveness Of Sunitinib Vs IFN-Alfa Or Bevacizumab + IFN-Alfa As First-Line Treatment In MRCC In Central America And The Caribbean
Brief SummaryPrimary 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 DescriptionThis 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 TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationAdult 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.
ConditionMetastatic Renal Cell Carcinoma
InterventionDrug: Sunitinib
Treatment for mRCC as indication approved and physician criterium
Study Groups/CohortsCentral 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 StatusTerminated
Actual Enrollment
 (submitted: August 19, 2011)		4
Original Estimated Enrollment
 (submitted: December 15, 2009)		12
Actual Study Completion DateFebruary 2011
Actual Primary Completion DateFebruary 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesPanama
Removed Location CountriesDominican Republic,   Honduras
 
Administrative Information
NCT NumberNCT01033981
Other Study ID NumbersA6181189
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2012

FOR MORE INFORMATION

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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