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

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ClinicalTrials.gov Identifier: NCT01098500
Recruitment Status : Completed
First Posted : April 2, 2010
Results First Posted : July 7, 2011
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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).

Condition or disease Intervention/treatment
Cancer Drug: Tyrosine kinase inhibitors

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.

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Study Type : Observational
Actual Enrollment : 3800 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs Using the LabRx Database
Study Start Date : February 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Tyrosine

Group/Cohort Intervention/treatment
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
Lapatinib, erlotinib, gefitinib, dasatinib, imatinib, nilotinib (analyzed as a class of drugs, not by individual drug)




Primary Outcome Measures :
  1. Number of Patients With ALT (Alanine Transaminase) >=3x (Times) Upper Limit of Normal (ULN) [ Time Frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. ]
    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).

  2. Incidence of ALT >=3x ULN [ Time Frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. ]
    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.

  3. Number of Hy's Law Patients (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN) [ Time Frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. ]
    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).

  4. Incidence of Hy's Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN) [ Time Frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. ]
    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.


Secondary Outcome Measures :
  1. Maximum ALT Elevation Reached During Follow-up [ Time Frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. ]
    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

  2. Median Time to the Maximum ALT Elevation During Follow-up [ Time Frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. ]
    Median time (in months) between index date and the date of maximum ALT elevation.

  3. Maximum AST Elevation Reached During Follow-up [ Time Frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. ]
    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

  4. Median Time to the Maximum AST Elevation During Follow-up [ Time Frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. ]
    Median time (in months) between index date and date of maximum AST elevation

  5. Maximum ALP Elevation Reached During Follow-up [ Time Frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. ]
    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

  6. Median Time to the Maximum ALP Elevation During Follow-up [ Time Frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. ]
    Median time (in months) between index date and date of maximum ALP elevation

  7. Maximum BIL Elevation Reached During Follow-up [ Time Frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. ]
    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

  8. Median Time to the Maximum BIL Elevation During Follow-up [ Time Frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date. ]
    Median time (in months) between index date and date of maximum BIL elevation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01098500


Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01098500     History of Changes
Other Study ID Numbers: 113153
WEUKSTV3635 ( Other Identifier: GSK )
EPI40661 ( Other Identifier: GSK )
First Posted: April 2, 2010    Key Record Dates
Results First Posted: July 7, 2011
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by GlaxoSmithKline:
Liver function
Tyrosine Kinase Inhibitor