Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients
NCT01073644
Last updated date
ABOUT THIS STUDY
The primary purpose is to monitor the safety and tolerability and effectiveness of sunitinib
malate in the treatment of patients with metastatic renal cell carcinoma and gastrointestinal
stromal tumor among filipino patients in usual clinical practice setting.
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
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Age 18 years and above
- Diagnosed with metastatic renal cell carcinoma or gastrointestinal stromal tumor after imatinib treatment failure or intolerance
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Subjects with conditions that are contraindicated with sunitinib malate
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients | |||
| Official Title | Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients | |||
| Brief Summary | The primary purpose is to monitor the safety and tolerability and effectiveness of sunitinib malate in the treatment of patients with metastatic renal cell carcinoma and gastrointestinal stromal tumor among filipino patients in usual clinical practice setting. | |||
| Detailed Description | Open label | |||
| 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 | Study population will be selected by primary care clinic. | |||
| Condition | Metastatic Renal Cell Carcinoma | |||
| Intervention | Drug: Sunitinib malate
sunitinib 50 mg, 4 weeks on, 2 weeks off Other Name: Sutent | |||
| Study Groups/Cohorts | Sunitinb malate
Intervention: Drug: Sunitinib malate | |||
| 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 | Terminated | |||
| Actual Enrollment | 3 | |||
| Original Estimated Enrollment | 20 | |||
| Actual Study Completion Date | April 2010 | |||
| Actual Primary Completion Date | April 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 18 Years to 75 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Philippines | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01073644 | |||
| Other Study ID Numbers | A6181118 | |||
| 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 2013 | |||