Last updated: 11/07/2018 05:43:21

Liver Function Test (LFT) elevations in cancer patients and users of tyrosine kinase inhibitor (TKI) drugs

GSK study ID
113153
See study documents
Clinicaltrials.gov ID
NCT01098500
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Liver Function Test (LFT) elevations in cancer patients and users of tyrosine kinase inhibitor (TKI) drugs using the LabRx Database
Trial description: 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).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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.

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.

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.

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:

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.

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.

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.

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.

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.

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.

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.

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.

Interventions:
  • Drug: Tyrosine kinase inhibitors
    • Enrollment:
    3800
    Primary completion date:
    2012-06-02
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Landis S, Nordstrom B, Sansbury L, Shantakumar S, St. Lawrence S, Fraeman K, Nelson J. Tyrosine Kinase Inhibiting Drugs and Disruptions in Liver Function in an Oncology Setting: Comparisons of Two Population-based Databases . J Cancer Epidemiol. 2013;13(Article ID 358285):
    Medical condition
    Cancer
    Product
    lapatinib
    Collaborators
    Not applicable
    Study date(s)
    February 2009 to February 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • o 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
    • o At least one month (30 days) of enrolment prior to index date and three months (91 days) of follow-up post index date; and
    • 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
    Inclusion and exclusion criteria
    Inclusion criteria:
    • o 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 o At least one month (30 days) of enrolment prior to index date and three months (91 days) of follow-up post index date; and o 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2012-06-02
    Actual study completion date
    2012-06-02

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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