Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs

Cancer Clinical Trial

Official title:

Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs Using the LabRx Database

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098500
• Other study ID #: 113153
• Secondary ID: WEUKSTV3635EPI40
• Status: Completed
• Phase: N/A
• First received: April 1, 2010
• Last updated: May 25, 2017
• Start date: February 2009
• Est. completion date: October 2010

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3800
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Tyrosine kinase inhibitors
Lapatinib, erlotinib, gefitinib, dasatinib, imatinib, nilotinib (analyzed as a class of drugs, not by individual drug)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With ALT (Alanine Transaminase) >=3x (Times) Upper Limit of Normal (ULN)	Prevalence of patients with an ALT elevation >=3x ULN among patients who had liver function testing during the baseline period (30 days prior to initiation of TKI drug).	Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Primary	Incidence of ALT >=3x ULN	Number of patients with ALT >=3 times ULN among patients with a normal ALT measurement during the baseline period (30 days prior to initiation of TKI drug). Normal is defined as an ALT <1 times ULN at baseline.	Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Primary	Number of Hy's Law Patients (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN)	Prevalence of patients with Hy's Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN, where AST = aspartate transaminase, ALP = alkaline phosphatase, BIL= bilirubin) among patients who had liver function testing during the baseline period (30 days prior to initiation of TKI drug).	Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Primary	Incidence of Hy's Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN)	Number of patients with Hy's Law (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN) among patients with normal ALT, AST, ALP, and BIL measurements during the baseline period (30 days prior to initiation of TKI drug). Normal is defined as an ALT AST, ALP, and BIL <1 times ULN at baseline.	Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Secondary	Maximum ALT Elevation Reached During Follow-up	Number of patients whose maximum ALT elevation fell within the indicated ULN range among patients with at least one incident ALT elevation during follow-up	Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Secondary	Median Time to the Maximum ALT Elevation During Follow-up	Median time (in months) between index date and the date of maximum ALT elevation.	Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Secondary	Maximum AST Elevation Reached During Follow-up	Number of patients whose maximum AST elevation fell within the indicated ULN range among patients with at least one incident AST elevation during follow-up	Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Secondary	Median Time to the Maximum AST Elevation During Follow-up	Median time (in months) between index date and date of maximum AST elevation	Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Secondary	Maximum ALP Elevation Reached During Follow-up	Number of patients whose maximum ALP elevation fell within the indicated ULN range among patients with at least one incident ALP elevation during follow-up	Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Secondary	Median Time to the Maximum ALP Elevation During Follow-up	Median time (in months) between index date and date of maximum ALP elevation	Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Secondary	Maximum BIL Elevation Reached During Follow-up	Number of patients whose maximum BIL elevations fell within the indicated ULN range among patients with at least one incident BIL elevation during follow-up	Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.
Secondary	Median Time to the Maximum BIL Elevation During Follow-up	Median time (in months) between index date and date of maximum BIL elevation	Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.