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.
- 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.)
- Patients not administered XALKORI in spite of enrolled.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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 Jul 1;49(7):676-686. doi: 10.1093/jjco/hyz049. | ||||
| * 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 | 2029 | ||||
| Original Estimated Enrollment | 2000 | ||||
| Actual Study Completion Date | March 16, 2018 | ||||
| Actual Primary Completion Date | March 16, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender |
| ||||
| 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 |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | September 2019 | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
