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Trial record 1 of 1 for:    NCT01597258
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Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)

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ClinicalTrials.gov Identifier: NCT01597258
Recruitment Status : Completed
First Posted : May 14, 2012
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date May 10, 2012
First Posted Date May 14, 2012
Last Update Posted Date March 27, 2018
Actual Study Start Date May 2012
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 10, 2012)
The incidence of adverse drug reactions in this surveillance. [ Time Frame: 52 weeks ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01597258 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 10, 2012)
Objective Response Rate (ORR) at 52 weeks. [ Time Frame: 52 weeks ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)
Official Title Special Investigation Of Xalkori For Nsclc (Regulatory Post Marketing Commitment Plan)
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients whom an investigator involving A8081031 prescribes the Crizotinib (XALKORI).
Condition Non-small Cell Lung Cancer
Intervention Drug: Crizotinib (Xalkori)
XALKORI® Capsule 200 mg/XALKORI® Capsule 250 mg This surveillance is all cases surveillance based on Japanese regulation. Frequency and duration are according to Package Insert as follows. " The recommended dose schedule of crizotinib is 250 mg taken orally twice daily. Dosing interruption and/or dose reduction may be required based on patients' clinical status. "
Other Name: XALKORI® Capsule 200 mg/XALKORI® Capsule 250 mg
Study Groups/Cohorts Crizotinib (Xalkori)
Intervention: Drug: Crizotinib (Xalkori)
Publications * Ueno N, Banno S, Endo Y, Tamura M, Sugaya K, Hashigaki S, Ohki E, Yoshimura A, Gemma A. Treatment status and safety of crizotinib in 2028 Japanese patients with ALK-positive NSCLC in clinical settings. Jpn J Clin Oncol. 2019 Apr 22. pii: hyz049. doi: 10.1093/jjco/hyz049. [Epub ahead of print]

*   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
 (submitted: February 15, 2017)
2044
Original Estimated Enrollment
 (submitted: May 10, 2012)
2000
Actual Study Completion Date March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (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 NCT01597258
Other Study ID Numbers A8081031
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
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2018