Clinical trial NCT01098500: Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs
Official title: Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs Using the LabRx Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Liver function
Tyrosine Kinase Inhibitor
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-04-02
Enrollment: 3800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective cohort study using the LabRx medical claims EMR database. This database contains medical claims information including diagnoses, treatments, medications, and laboratory results for 23.3 million US residents. The study cohort included adult patients (age ≥18 years) with any cancer diagnosed between October 1, 2004-June 1, 2009 who were treated with 1 one or more of the TKI agents-erlotinib, gefitinib, dasatinib, imatinib, nilotinib, or lapatinib. The index date for this cohort was the date of first administration or prescription of the TKI agent on or following the date of the first cancer diagnosis.

Brief summary: A retrospective cohort study using the LabRx medical claims database will be performed to address these objectives. The primary objective of this project is to examine the background rates of liver function test (LFT) abnormalities in cancer patients treated with tyrosine kinase inhibitors (TKIs).

Detailed description: Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Eligibility criteria: Inclusion Criteria:

* Adult (age ≥18 years) with at least two ICD-9 codes for a particular cancer (ICD-9 code 140-208.9) within a 6 month timeframe and at least one code for a TKI drug that occurs on or after the first cancer diagnosis code
* At least one month (30 days) of enrolment prior to index date and three months (91 days) of follow-up post index date; and
* Continuous enrolment in the LabRx database during follow-up.

Exclusion Criteria:

* Less than 18 years old
* Less than one month (30 days) of enrolment prior to index date or three months (91 days) of follow-up post index date; and
* Not continuously enrolled in the LabRx database during follow-up.

Primary outcomes:
measure: Number of Patients With ALT (Alanine Transaminase) >=3x (Times) Upper Limit of Normal (ULN)
timeFrame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
measure: Incidence of ALT >=3x ULN
timeFrame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
measure: Number of Hy's Law Patients (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN)
timeFrame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
measure: Incidence of Hy's Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN)
timeFrame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Secondary outcomes:
measure: Maximum ALT Elevation Reached During Follow-up
timeFrame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
measure: Median Time to the Maximum ALT Elevation During Follow-up
timeFrame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
measure: Maximum AST Elevation Reached During Follow-up
timeFrame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
measure: Median Time to the Maximum AST Elevation During Follow-up
timeFrame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
measure: Maximum ALP Elevation Reached During Follow-up
timeFrame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
measure: Median Time to the Maximum ALP Elevation During Follow-up
timeFrame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
measure: Maximum BIL Elevation Reached During Follow-up
timeFrame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
measure: Median Time to the Maximum BIL Elevation During Follow-up
timeFrame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: