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

NCT01098500 | Completed Results

• 3 other identifiers: 113153WEUKSTV3635EPI40661
• Study Type: observational
• Target: 3,800
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Cancer

Keywords

Liver function; Tyrosine Kinase Inhibitor

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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 Outcomes (8)

• Maximum ALT Elevation Reached During Follow-up

  Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

• Median Time to the Maximum 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.

• Maximum AST Elevation Reached During Follow-up

  Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

• Median Time to the Maximum 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.

• Maximum ALP Elevation Reached During Follow-up

  Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

Study Arms (1)

Cancer patients

Adults (age ≥18 years) with at least two ICD-9 codes for a particular cancer within a 6 month timeframe and at least one code for a TKI drug that occurs on or after the first cancer diagnosis code

Drug: Tyrosine kinase inhibitors

Interventions

Tyrosine kinase inhibitors DRUG

Lapatinib, erlotinib, gefitinib, dasatinib, imatinib, nilotinib (analyzed as a class of drugs, not by individual drug)

Cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Neoplasms

Interventions

Tyrosine Kinase Inhibitors

Intervention Hierarchy (Ancestors)

Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 2, 2010
• Study Start: February 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 30, 2017
• Results First Posted: July 7, 2011

Record last verified: 2017-05