Cost Effectiveness Of Sunitinib In Central America And Caribbean
NCT01033981
Last updated date
ABOUT THIS STUDY
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
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
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
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 | 4 | |||
| Original Estimated Enrollment | 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:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | April 2012 | |||