Post-Marketing Surveillance Study To Observe INLYTA® Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice

NCT02533258 | Completed Results

• 2 other identifiers: A4061076NCT02533258
• Study Type: observational
• Target: 13
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Cell Carcinoma

Keywords

advanced renal cell carcinoma, disease progression, sunitinib, interferon alpha

Outcome Measures

Primary Outcomes (2)

• Duration of Axitinib Treatment

  From initiation of axitinib treatment up to the end of the study (up to 40 months)

• Mean Daily Dose of Axitinib

  From initiation of axitinib treatment up to the end of the study (up to 40 months)

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  From initiation of axitinib treatment until PD or death from any cause (up to 40 months)

• Duration of Response

  From initiation of axitinib treatment until PD or death from any cause (up to 40 months)

• Progression-Free Survival (PFS)

  From initiation of axitinib treatment until PD or death from any cause (up to 40 months)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From initiation of axitinib treatment up to end of the study (up to 40 months)

• Number of Participants With Adverse Events (AEs) by Severity

  From initiation of axitinib treatment up to end of the study (up to 40 months)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

advanced renal cell carinoma with disease progression on sunitinib or interferon

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Renal Cell; Disease Progression

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: August 26, 2015
• Study Start: December 2, 2015
• Primary Completion: May 12, 2016
• Study Completion: May 12, 2016
• Last Updated: July 16, 2025
• Results First Posted: October 5, 2017

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share