Metastatic Renal Cell CarcinomaNCT01033981
Cost Effectiveness Of Sunitinib In Central America And Caribbean
An observational study of Metastatic Renal Cell Carcinoma, run by Pfizer at 1 site in Panama.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Sunitinib
- How many people
- 4 participants
- Where
- 1 sitePanama
- Study dates
- May 2010to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult men and women with mRCC will be evaluated for entering the study. The decision to use Sunitinib, IFN-α 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Sunitinib
- Keywords
- cost effectiveness, Sunitinib Central America and Caribbean Metastatic Renal Cell Carcinoma
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Treatment for mRCC as indication approved and physician criterium
| Study group | Role | What they receive |
|---|---|---|
| Central America and Caribbean | Dominican Republic, Guatemala, Panama, Costa Rica, Honduras, Trinidad \& Tobago Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients that present metastasis when consulting for first time
Measured: 9 months
Rate of use of Sutent, IFN-α and Bevacizumab + IFN-α as first-line treatment
Measured: 9 months
Hospitalization average with Sutent, with IFN-α, and with Bevacizumab + IFN-α
Measured: 9 months
Rate of success in first-line treatment with Sutent, in first-line treatment with IFN-α and in first-line treatment with Bevacizumab + IFN-α
Measured: 9 months
Average number of cycles of Sutent, IFN-α and Bevacizumab + IFN in first-line treatment
Measured: 9 months
Secondary outcomes (7)
Percentage of adverse effects with the use of Sunitinib, IFN-α and Bevacizumab + IFN
Measured: 9 months
Quality of life in patients using an approved quality questionnaire
Measured: 9 months
Costs-benefit of each treatment
Measured: 9 months
PFY (progression free years) with each treatment
Measured: 9 months
LY (life years) with each treatment
Measured: 9 months
QALYs (quality adjusted life years) with each treatment
Measured: 9 months
ICER (incremental cost effectiveness ratio) of PFY and LY with each treatment
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startMay 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033981
- Sponsor's protocol ID
- A6181189
- Status last verified
- Apr 2012
- First submitted
- 14 Dec 2009
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01033981
- Acronym / sponsor ID
- A6181189
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- cost effectiveness, Sunitinib Central America and Caribbean Metastatic Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 17 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Central America and Caribbean | – | Drug: SunitinibDominican Republic, Guatemala, Panama, Costa Rica, Honduras, Trinidad \& Tobago |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult men and women with mRCC will be evaluated for entering the study. The decision to use Sunitinib, IFN-α 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SunitinibTreatment for mRCC as indication approved and physician criterium | Drug | Central America and Caribbean |
Primary outcome
Rate of patients that present metastasis when consulting for first time
Time frame: 9 months
Rate of use of Sutent, IFN-α and Bevacizumab + IFN-α as first-line treatment
Time frame: 9 months
Hospitalization average with Sutent, with IFN-α, and with Bevacizumab + IFN-α
Time frame: 9 months
Rate of success in first-line treatment with Sutent, in first-line treatment with IFN-α and in first-line treatment with Bevacizumab + IFN-α
Time frame: 9 months
Average number of cycles of Sutent, IFN-α and Bevacizumab + IFN in first-line treatment
Time frame: 9 months
7 secondary outcomes
Percentage of adverse effects with the use of Sunitinib, IFN-α and Bevacizumab + IFN
Time frame: 9 months
Quality of life in patients using an approved quality questionnaire
Time frame: 9 months
Costs-benefit of each treatment
Time frame: 9 months
PFY (progression free years) with each treatment
Time frame: 9 months
LY (life years) with each treatment
Time frame: 9 months
QALYs (quality adjusted life years) with each treatment
Time frame: 9 months
ICER (incremental cost effectiveness ratio) of PFY and LY with each treatment
Time frame: 9 months
Results and safety
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Renal Cell Carcinoma, run by Pfizer at 1 site in Panama.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients that present metastasis when consulting for first time (time frame: 9 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2012.