CancerNCT01098500

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

An observational study of Cancer, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer
What is being tested?: Tyrosine kinase inhibitors
How many people: 3,800 participants
Where: No sites listed yet
Study dates: Feb 2009to Oct 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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.

About this study

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

Read the 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.

Conditions: Cancer
Being tested: Tyrosine kinase inhibitors
Keywords: Liver function, Tyrosine Kinase Inhibitor
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01098500
Study group	Role	What they receive
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 Receives: Drug: Tyrosine kinase inhibitors

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
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
Measured: 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
Median time (in months) between index date and the date of maximum ALT elevation.
Measured: 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
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
Measured: 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
Median time (in months) between index date and date of maximum AST elevation
Measured: 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
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
Measured: 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
Median time (in months) between index date and date of maximum ALP elevation
Measured: 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
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
Measured: 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
Median time (in months) between index date and date of maximum BIL elevation
Measured: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Oct 2010

First posted2 Apr 2010 (estimated)
Study startFeb 2009
Primary completionOct 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CancerStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 3,800 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01098500
Sponsor's protocol ID: 113153
Other IDs: WEUKSTV3635, EPI40661
Status last verified: May 2017
First submitted: 1 Apr 2010
Last updated: 30 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs Using the LabRx Database
ClinicalTrials.gov ID: NCT01098500
Acronym / sponsor ID: 113153
Conditions: Cancer
Keywords: Liver function, Tyrosine Kinase Inhibitor
Study type: Observational
Recruitment status: Completed
Enrolment: 3,800 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 2 Apr 2010 (estimated)
Results: Posted 7 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Cancer patients	–	Drug: Tyrosine kinase inhibitorsAdults (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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tyrosine kinase inhibitorsLapatinib, erlotinib, gefitinib, dasatinib, imatinib, nilotinib (analyzed as a class of drugs, not by individual drug)	Drug	Cancer patients

Primary outcome

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).
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.
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).
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.

8 secondary outcomes

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.
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.
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.
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.
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.
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.
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.
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.

Results and safety

Results posted to the registry on 7 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TKI Cohort	3,800	3,800

Primary outcome: 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.. Number. Unit: participants

Measure	TKI Cohort n = 498
Value	11

TKI Cohort: Prevalence percentage: 2.2 (95% CI 0.9 to 3.5)

Population analysed: Members of the TKI cohort who had liver function testing within 30 days prior to the initiation of TKI drug.

Primary outcome: 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. Unit: participants

Measure	TKI Cohort n = 344
Value	18

TKI Cohort: Incidence Rate (IR): 6.2 (95% CI 3.3 to 9.0)

Population analysed: Members of the TKI cohort who had normal ALT (\<1x ULN) during baseline (within 30 days prior to the initiation of TKI drug)

Primary outcome: 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.. Number. Unit: participants

Measure	TKI Cohort n = 500
Value	2

TKI Cohort: Prevalence percentage: 0.4 (95% CI 0.1 to 1.4)

Population analysed: Members of the TKI cohort who had liver function testing within 30 days prior to the initiation of TKI drug).

Primary outcome: 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. Unit: participants

Measure	TKI Cohort n = 307
Value	1

TKI Cohort: Incidence Rate (IR): 0.4 (95% CI 0.0 to 2.0)

Population analysed: Members of the TKI cohort who had normal ALT, AST, ALP, and BIL (\<1x ULN) during baseline (within 30 days prior to the initiation of TKI drug).

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TKI Cohort	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01098500.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.