In this study we want to determine the erlotinib concentrations in blood after administration of erlotinib with water or whole milk with and without an antacid .
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in the bioavailabiliteit of erlotinib in patients taking a PPI
or not , with or without milk.
Secondary outcome
Comparison of toxicity and side effects of erlotinib taken with water or milk .
Background summary
Erlotinib in patients with lung cancer may be less efficient due to interaction
with PPIs . Since erlotinib is more readily soluble in fat, relative to water ,
erlotinib is likely to dissolve better after ingestion of a fatty meal such as
milk leading eventually to higher erlotinib levels in blood. In addition,
cancer patients often suffer from their stomach and they should use an antacid
before. As erlotinib and an antacid may be taken at the same time then by
interacting decrease blood level of erlotinib may be observed.
Study objective
In this study we want to determine the erlotinib concentrations in blood after
administration of erlotinib with water or whole milk with and without an
antacid .
Study design
A single centre, randomized, cross-over pharmacokinetic study.
Study burden and risks
A possible burden for a patient may be that he or she has to be admitted to the
hospital twice for pharmacokinetic blood sampling. In order to obtain the blood
samples an infusion needle is inserted. Another possible burden is that
medication has to be taken at precise times during the study and patients are
asked to keep a diary. If milk ensures that the blood levels of erlotinib go
up, this could lead to possible side effects of erlotinib. However, this will
take up to a week, and we expect that this short period will have no
significant impact on treatment. The antacid esomeprazole ( Nexium® ) is
generally well tolerated , but it is possible that it still may cause side
effects.
's-Gravendijkwal 230
Rotterdam 3015CE
NL
's-Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
1. Age * 18
2. Use of erlotinib monotherapy for at least 14 days (to guarantee steady-state) and willing to continue the treatment until the end of the study
3. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
Exclusion criteria
1. Age < 18 years
2. Pregnant or lactating patients
3. Impossibility to take oral drugs
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-001597-15-NL |
| CCMO | NL59013.078.16 |