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Safety and Efficacy of Xalkori ROS1

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer local country office
Tokyo, , Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-small Cell Lung Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT03375242
Pfizer
Recruiting
Safety and Efficacy of Xalkori ROS1

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Safety and Efficacy of Xalkori ROS1
Xalkori Ros1+Nsclc Drug Use Investigation
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
100 patients
Non-small Cell Lung Cancer
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
crizotinib
Intervention: Drug: crizotinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
August 30, 2021
August 30, 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Japan
 
 
NCT03375242
A8081051
No
Not Provided
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/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2018

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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