Lung CancerNCT02904850
Validation of a Kinetic Model of Erlotinib
An observational study of Lung Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Several arguments are in favor of a therapeutic monitoring for the erlotinib, therefore, a pharmacokinetic (PK) has been prepared using data from the literature. This model must be validated at concentrations achieved in practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- group of patients
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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: patients treated in the care departement of the hospital
Who may be able to join
- All patients receiving treatment with erlotinib monotherapy for locally advanced or metastatic NSCLC either first line in patients with an activating mutation of the receptor EGF-R or patients with stable disease after 4 cycles of standard first-line chemotherapy with platinum or after failure of at least one prior chemotherapy regimen
- Age> 18 years
- Subject has signed an informed consent
- Treatment initiated for at least 7 days or dosage changed for at least 7 days
Who cannot join
- Contraindication to the use of drug
- Subject to exclusion period (as determined by a previous study or in progress)
- Inability to give informed information (subject in emergency situations, difficulties in understanding the subject, ...)
- Subject under judicial protection
- Subject under tutorship or curatorship
- Pregnancy (and woman of childbearing age without contraception)
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Pneumologie Nouvel Hôpital Civil
Strasbourg, Alsace, 67091
Bertrand MENNECIER
Alain DUCOLONE
About this study
Several arguments are in favor of a therapeutic monitoring for the erlotinib, therefore, a pharmacokinetic (PK) has been prepared using data from the literature. This model must be validated at concentrations achieved in practice. This is a preliminary study before the implementation of a randomized trial confirming the therapeutic monitoring of erlotinib through this model.
- Conditions
- Lung Cancer
- Being tested
- group of patients
- Keywords
- Non-small cell lung cancer, locally advanced or metastatic, erlotinib monotherapy
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group of patientsBiological
Plasma dosage of erlotinib and OSI-420 is made from the blood usually taken Further information are collected in the medical record of the patient during the CT scan reassessment after collection.
| Study group | Role | What they receive |
|---|---|---|
| group of patients | Plasma dosage of erlotinib and OSI-420 Receives: Biological: group of patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between plasma concentrations of erlotinib concentrations observed and predictive model
Measured: 1 year
Secondary outcomes (1)
Correlation of Blood levels outsized with severe side effects or compromising the vital prognosis (treatment response, adherence (assessed by the test Morisky Green)
Evaluation of interest to assay the active metabolite OSI-420 Observation between incidence of clinical problems (ineffectiveness, toxicity, adherence) and blood concentrations of erlotinib outsized.
Evaluation of the potential clinical benefit to provide a dosage of erlotinib
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startJun 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Elisabeth QUOIX, Principal investigator, Service Pneumologie Hôpitaux Universitaires Strasbourg 67 091 STRASBOURG cedex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904850
- Sponsor's protocol ID
- 5615
- Other IDs
- 2013-A01122-43
- Status last verified
- Sep 2016
- First submitted
- 3 Apr 2014
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Kinetic Model of Erlotinib
- ClinicalTrials.gov ID
- NCT02904850
- Acronym / sponsor ID
- 5615
- Conditions
- Lung Cancer
- Keywords
- Non-small cell lung cancer, locally advanced or metastatic, erlotinib monotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several arguments are in favor of a therapeutic monitoring for the erlotinib, therefore, a pharmacokinetic (PK) has been prepared using data from the literature. This model must be validated at concentrations achieved in practice. This is a preliminary study before the implementation of a randomized trial confirming the therapeutic monitoring of erlotinib through this model.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group of patients | – | Biological: group of patientsPlasma dosage of erlotinib and OSI-420 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated in the care departement of the hospital
Key inclusion criteria (4 listed)
- All patients receiving treatment with erlotinib monotherapy for locally advanced or metastatic NSCLC either first line in patients with an activating mutation of the receptor EGF-R or patients with stable disease after 4 cycles of standard first-line chemotherapy with platinum or after failure of at least one prior chemotherapy regimen
- Age> 18 years
- Subject has signed an informed consent
- Treatment initiated for at least 7 days or dosage changed for at least 7 days
Key exclusion criteria (7 listed)
- Contraindication to the use of drug
- Subject to exclusion period (as determined by a previous study or in progress)
- Inability to give informed information (subject in emergency situations, difficulties in understanding the subject, ...)
- Subject under judicial protection
- Subject under tutorship or curatorship
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 |
|---|---|---|
| group of patientsPlasma dosage of erlotinib and OSI-420 is made from the blood usually taken Further information are collected in the medical record of the patient during the CT scan reassessment after collection. | Biological | group of patients |
Primary outcome
Difference between plasma concentrations of erlotinib concentrations observed and predictive model
Time frame: 1 year
1 secondary outcome
Correlation of Blood levels outsized with severe side effects or compromising the vital prognosis (treatment response, adherence (assessed by the test Morisky Green)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
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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.
Anne Elisabeth QUOIX principal investigator
Service Pneumologie Hôpitaux Universitaires Strasbourg 67 091 STRASBOURG cedex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Elisabeth QUOIX (03 69 55 03 78, elisabeth.quoix@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between plasma concentrations of erlotinib concentrations observed and predictive model (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2016.