Study In Patients With Kidney Cancer Treated With Sutent
NCT00873210
ABOUT THIS STUDY
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- Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy
- Hypersensitivity to sunitinib malate or to any of the excipients
- Any other contraindication to the use of sunitinib malate (based on decision of the
treating physician).
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Descriptive Information | ||||
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Brief Title | Study In Patients With Kidney Cancer Treated With Sutent | |||
Official Title | Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With Sutent | |||
Brief Summary | Objective of this study is to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib. | |||
Detailed Description | Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | Patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy. | |||
Condition |
| |||
Intervention | Drug: Sutent
50 mg per day for 4 consecutive weeks, followed by 2 weeks treatment pause Other Name: sunitinib malate | |||
Study Groups/Cohorts | Patients treated with Sutent
125 consecutive patients in outpatient care with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer 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 | 121 | |||
Original Estimated Enrollment | 100 | |||
Actual Study Completion Date | November 2011 | |||
Actual Primary Completion Date | November 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 | Slovakia | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00873210 | |||
Other Study ID Numbers | A6181185 | |||
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 | November 2012 |