Post-Marketing Surveillance Study To Observe INLYTA® Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice
NCT02533258
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Adult Trials: 18+ Years
- Patients diagnosed as advanced RCC by histology or cytology
- Patients using axitinib as therapy after failure of sunitinib or cytokine
- Patients received axitinib treatment and follow up in the health care center participating present registry
- Patients agree to participate and signed inform consent or IRB waiving of signed informed consent document is available
- Patients with first dose of axitinib earlier than 7th May 2013
- Patients with first dose of axitinib later than 30th June 2015.
- Patients participating in clinical research involving axitinib
- Patients with hypersensitivity to axitinib or to any other component of axitinib
- Patients under 18-year of age
- Pregnant women.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Post-Marketing Surveillance Study To Observe INLYTA® Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice | |||
| Official Title | Post-marketing Surveillance Study To Observe Inlyta (Registered) Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice | |||
| Brief Summary | This is a post-marketing Surveillance study to observe INLYTA® treatment dosing pattern, safety and effectiveness in Taiwan real world routine practice. The primary objective of this registry is to monitor the dose adjustment of INLYTA® in real world routine practice. The secondary objectives include safety profile, objective response rate, and progression-free rate in real world routine practice. | |||
| Detailed Description | This is a multi-center chart review registry on mRCC patients treated with axitinib. Primary objective is the dose adjustment. Secondary objectives are safety profile, objective response rate and progression free survival. Efficacy assessment will be based on investigators' judgment. Patients treated with 1st dose of axitinib between May 7, 2013 and June 30, 2015 will be enrolled. The follow-up time is 12 months. Prior therapies should include sunitinib or interferon alpha. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Retrospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | advanced renal cell carinoma with disease progression on sunitinib or interferon | |||
| Condition | Renal Cell Carcinoma | |||
| Intervention | Not Provided | |||
| Study Groups/Cohorts | Not Provided | |||
| 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 | 13 | |||
| Original Estimated Enrollment | 1 | |||
| Actual Study Completion Date | May 12, 2016 | |||
| Actual Primary Completion Date | May 12, 2016 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender | Not Provided | |||
| Ages | 18 Years to 85 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT02533258 | |||
| Other Study ID Numbers | A4061076 | |||
| 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 | April 2017 | |||