Non-small Cell Lung Cancer Clinical Trial
Official title:
SPECIAL INVESTIGATION OF XALKORI FOR NSCLC (REGULATORY POST MARKETING COMMITMENT PLAN)
NCT number | NCT01597258 |
Other study ID # | A8081031 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 29, 2012 |
Est. completion date | March 16, 2018 |
Verified date | September 2019 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2029 |
Est. completion date | March 16, 2018 |
Est. primary completion date | March 16, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Adverse Drug Reactions | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XALKORI Capsules in a participant who received XALKORI Capsules. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XALKORI Capsules was assessed by the physician. | 52 weeks | |
Secondary | Objective Response Rate (ORR) at 52 Weeks | Clinical effectiveness of XALKORI Capsules was assessed as "complete response (CR)", "partial response (PR)", "stable disease (SD)", "progressive disease (PD)", or "indeterminate" by the physician, based on Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. Overall effectiveness of XALKORI Capsules was determined by the physician based on the best response. Clinical effectiveness rate was ORR, defined as the percentage of subjects achieving CR or PR with best response. The ORR was presented along with the corresponding exact 2-sided 95% confidence interval (CI). | 52 weeks |
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