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

Renal Cell Carcinoma Clinical Trial

Official title:

Post-marketing Surveillance Study To Observe Inlyta (Registered) Treatment Dosing Pattern, Safety And Effectiveness In Taiwan Real World Routine Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533258
• Other study ID #: A4061076
• Status: Completed
• Phase: N/A
• First received: August 24, 2015
• Last updated: May 11, 2017
• Start date: December 2, 2015
• Est. completion date: May 12, 2016

Study information

• Verified date: April 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 12, 2016
• Est. primary completion date: May 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Axitinib Treatment		From initiation of axitinib treatment up to the end of the study (up to 40 months)
Primary	Mean Daily Dose of Axitinib		From initiation of axitinib treatment up to the end of the study (up to 40 months)
Secondary	Objective Response Rate (ORR)	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.	From initiation of axitinib treatment until PD or death from any cause (up to 40 months)
Secondary	Duration of Response	Duration of response was defined as time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per 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 (<10 mm short axis). PR was defined as at least 30% 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. PD was defined as >=20% increase in sum of diameters of the target lesions taking as a reference 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.	From initiation of axitinib treatment until PD or death from any cause (up to 40 months)
Secondary	Progression-Free Survival (PFS)	PFS was defined as the time duration in months from start of study treatment to the first documentation of PD or to death due to any cause, whichever occured first. PD was assessed by RECIST version 1.1. and defined as >=20% increase in the sum of the diameters of the target lesions taking as a 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 the appearance of 1 or more new lesions. Progression free survival based on investigators' judgment on medical records was calculated.	From initiation of axitinib treatment until PD or death from any cause (up to 40 months)
Secondary	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non--serious events.	From initiation of axitinib treatment up to end of the study (up to 40 months)
Secondary	Number of Participants With Adverse Events (AEs) by Severity	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE.	From initiation of axitinib treatment up to end of the study (up to 40 months)
Secondary	Number of Participants With Treatment-Related Adverse Events (AEs)	A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.	From initiation of axitinib treatment up to end of the study (up to 40 months)
Secondary	Number of Participants Discontinued Due to Adverse Events (AEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.	From initiation of axitinib treatment up to end of the study (up to 40 months)

External Links

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