Non-Interventional Study (NIS) In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®
NCT00684645
Last updated date
ABOUT THIS STUDY
Primary objective: to increase knowledge about safety, tolerability, quality of life and
efficacy under conditions of routine use of SUTENT®. Secondary objectives: treatment
response, hypothyroidism prevalence.The efficacy will be assessed using the Objective
Response Rate, Time to Progression based on the RECIST criteria and the ECOG performance
data.
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.
Show details
- Patients with advanced or metastatic renal cell carcinoma.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- No previous cytokines therapy.
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Non-Interventional Study (NIS) In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT® | |||
| Official Title | Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT® | |||
| Brief Summary | Primary objective: to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of SUTENT®. Secondary objectives: treatment response, hypothyroidism prevalence.The efficacy will be assessed using the Objective Response Rate, Time to Progression based on the RECIST criteria and the ECOG performance data. | |||
| Detailed Description | 180 patients will be enrolled at 20 key oncological centres, the sample size is sufficient for exploratory analysis. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| Study Population | Patients with metastatic and/or advanced renal cell carcinoma after failure of cytokines therapy. | |||
| Condition | Metastatic Renal Cell Carcinoma | |||
| Intervention | Drug: SUTENT
SUTENT® hard gelatin capsules containing 12.5 mg, 25 mg or 50 mg equivalent of sunitinib malate; daily dosage of 50 mg for 4 consecutive weeks followed by a 2-week rest period. Sutent is administered until disease progression or occurrence of unacceptable toxicity. | |||
| Study Groups/Cohorts | Patients treated with SUTENT®
Patients with metastatic or advanced renal cell carcinoma after failure of cytokines therapy. Intervention: Drug: SUTENT | |||
| 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 | Completed | |||
| Actual Enrollment | 186 | |||
| Original Estimated Enrollment | 180 | |||
| Actual Study Completion Date | April 2011 | |||
| Actual Primary Completion Date | April 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 | Czech Republic | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00684645 | |||
| Other Study ID Numbers | A6181171 | |||
| 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 | July 2012 | |||