Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Crizotinib (Xalkori)

• Registration Number: NCT01597258
• Lead Sponsor: Pfizer

Brief Summary

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Detailed Description

All the patients whom an investigator prescribes Crizotinib (XALKORI) should be registered.

Study Timeline

• Study First Submitted: 2012-05-10
• Study First Submitted QC: 2012-05-10
• Study First Posted: 2012-05-14
• Study Start: 2012-05-29
• Primary Completion: 2018-03-16
• Study Completion: 2018-03-16
• Results First Submitted: 2019-03-15
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-12
• Last Update Submitted: 2019-09-12
• Results First Posted: 2019-09-13
• Last Update Posted: 2019-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2029

Inclusion Criteria

• All the patients whom an investigator prescribes XALKORI. (Patients need to be administered Crizotinib (XALKORI) in order to be enrolled in this all cases surveillance.)

Exclusion Criteria

• Patients not administered XALKORI in spite of enrolled.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Crizotinib (Xalkori)	Crizotinib (Xalkori)	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Drug Reactions	52 weeks	An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XALKORI Capsules in a participant who received XALKORI Capsules. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XALKORI Capsules was assessed by the physician.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) at 52 Weeks	52 weeks	Clinical effectiveness of XALKORI Capsules was assessed as "complete response (CR)", "partial response (PR)", "stable disease (SD)", "progressive disease (PD)", or "indeterminate" by the physician, based on Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. Overall effectiveness of XALKORI Capsules was determined by the physician based on the best response. Clinical effectiveness rate was ORR, defined as the percentage of subjects achieving CR or PR with best response. The ORR was presented along with the corresponding exact 2-sided 95% confidence interval (CI).