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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01597258
First Posted: May 14, 2012
Last Update Posted: September 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention
Non-small Cell Lung Cancer Drug: Crizotinib (Xalkori)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Investigation Of Xalkori For Nsclc (Regulatory Post Marketing Commitment Plan)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The incidence of adverse drug reactions in this surveillance. [ Time Frame: 52 weeks ]

Secondary Outcome Measures:
  • Objective Response Rate (ORR) at 52 weeks. [ Time Frame: 52 weeks ]

Enrollment: 2044
Actual Study Start Date: May 29, 2012
Estimated Study Completion Date: January 31, 2018
Estimated Primary Completion Date: January 31, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Crizotinib (Xalkori) 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

Detailed Description:
All the patients whom an investigator prescribes Crizotinib (XALKORI) should be registered.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients whom an investigator involving A8081031 prescribes the Crizotinib (XALKORI).
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597258


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01597258     History of Changes
Other Study ID Numbers: A8081031
First Submitted: May 10, 2012
First Posted: May 14, 2012
Last Update Posted: September 13, 2017
Last Verified: September 2017

Keywords provided by Pfizer:
Safety
All cases surveillance in Japan
ALK-positive unresectable advanced and/or recurrent non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Crizotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action