Study In Patients With Kidney Cancer Treated With Sutent
NCT00873210
Last updated date
ABOUT THIS STUDY
Objective of this study is to increase knowledge about safety, tolerability, quality of life
and efficacy under conditions of routine use of sunitinib.
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.
Advanced or Metastatic Renal Cell Carcinoma, Renal Cancer
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
- Consecutive patients with advanced or metastatic renal cell carcinoma, that are indicated for 1st or 2nd line anticancer therapy
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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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Advanced or Metastatic Renal Cell Carcinoma, Renal CancerStudy In Patients With Kidney Cancer Treated With Sutent
NCT00873210
- Banska Bystrica,
- Bojnice,
- Bratislava,
- Bratislava,
- Kosice,
- Michalovce,
- Nitra,
- Poprad,
- Presov,
- Ruzomberok,
- Trebisov,
- Trencin,
- Trnava,
- Zilina,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| 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 | |||