Clinical trial · Observational
Post-Marketing Surveillance Study To Observe INLYTA® Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice
POST-MARKETING SURVEILLANCE STUDY TO OBSERVE INLYTA (REGISTERED) TREATMENT DOSING PATTERN, SAFETY AND EFFECTIVENESS IN TAIWAN REAL WORLD ROUTINE PRACTICE
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Duration of Axitinib Treatment
- timeFrame
- From initiation of axitinib treatment up to the end of the study (up to 40 months)
- measure
- Mean Daily Dose of Axitinib
- timeFrame
- From initiation of axitinib treatment up to the end of the study (up to 40 months)
Secondary outcomes (7)
- measure
- Objective Response Rate (ORR)
- timeFrame
- From initiation of axitinib treatment until PD or death from any cause (up to 40 months)
- description
- ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version 1.1. CR was defined as disappearance of all target, non-target lesions and all lymph nodes decreased to non-pathological in size (less than \[\<\]10 millimeter \[mm\] short axis). PR was defined as at least 30 percent (%) decrease in sum of diameters of target lesions taking as reference the baseline sum, without progression of non-target lesions, no appearance of new lesions. Progression of disease (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Response evaluation was based on investigators' judgment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available