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Safety and Efficacy of Xalkori ROS1

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ClinicalTrials.gov Identifier: NCT03375242
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Drug: crizotinib

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Xalkori Ros1+Nsclc Drug Use Investigation
Actual Study Start Date : October 25, 2017
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Crizotinib

Group/Cohort Intervention/treatment
crizotinib Drug: crizotinib
XALKORI® Capsule 200 mg/XALKORI® Capsule 250 mg 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




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

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 12, 24, 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
100 patients
Criteria

Inclusion Criteria:

  • patients with unresectable progressive/recurrent NSCLC who are naive to XALKORI and whose tumor is ROS1 gene positive

Exclusion Criteria:

  • Patients with past history of hypersensitivity to any of the ingredients of XALKORI

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): NCT03375242


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Japan
Pfizer local country office Recruiting
Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03375242     History of Changes
Other Study ID Numbers: A8081051
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

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