Variations in plasma concentration in patients with non-small cell lung cancer on fixed-dose erlotinib

Status

Active, not recruiting

Phases

Phase 1Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004350-29-DK

Enrollment

Unknown

Registered

2012-10-26

Start date

2012-12-05

Completion date

Unknown

Last updated

2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

Trade Name: tarceva Product Name: tarceva Pharmaceutical Form: Tablet Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: lung cancer taking erlotinib informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
Main Objective: The hypothesis of the project is that erlotinib given as at a fixed dose of 150mg to all patients’ results in a variable plasma concentration of the drug. This would in turn lead to a variation in anticancer effect and toxicity. The project will determine the size of this person-person variability. Should a sizeable difference be found, it would indicate the need for further studies of potential differences in anticancer activity and toxicity and a re-assessment of drug dosage.Erlotinib hydrochloride is the active substance of Tarceva, which is used to treat advanced stage non small cell lung cancer and pancreatic cancer. This project deals with non small cell lung cancer (NSCLC) patients only. Erlotinib is a reversible tyrosine kinase inhibitor (TKI), that specifically targets the epidermal growth factor receptor (EGFR), which is sometimes highly expressed and occasionally mutated in various forms of cancer. ;Secondary Objective: None;Primary end point(s): Standard deviation of plasma concentrations of erlotinib;Timepoint(s) of evaluation of this end point: A bloodsample taken anytime from individuals on erlotinib	—

Measure

Time frame

Main Objective: The hypothesis of the project is that erlotinib given as at a fixed dose of 150mg to all patients’ results in a variable plasma concentration of the drug. This would in turn lead to a variation in anticancer effect and toxicity. The project will determine the size of this person-person variability. Should a sizeable difference be found, it would indicate the need for further studies of potential differences in anticancer activity and toxicity and a re-assessment of drug dosage.Erlotinib hydrochloride is the active substance of Tarceva, which is used to treat advanced stage non small cell lung cancer and pancreatic cancer. This project deals with non small cell lung cancer (NSCLC) patients only. Erlotinib is a reversible tyrosine kinase inhibitor (TKI), that specifically targets the epidermal growth factor receptor (EGFR), which is sometimes highly expressed and occasionally mutated in various forms of cancer. ;Secondary Objective: None;Primary end point(s): Standard deviation of plasma concentrations of erlotinib;Timepoint(s) of evaluation of this end point: A bloodsample taken anytime from individuals on erlotinib

—

Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: n/a	—

Countries

Denmark

Contacts

Public Contactanders mellemgaard

herlev hospital

anders.mellemgaard@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026