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
Metastatic Renal Cell Carcinoma
Sex
Females and Males
Age
18 + years
Inclusion Criteria
Show details
- Patients with advanced or metastatic renal cell carcinoma.
Exclusion Criteria
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 |