A pharmacokinetics study of edoxaban in non-small cell lung cancer patients harboring EGFR mutation.
- Conditions
- on-small cell lung cancer
- Registration Number
- JPRN-jRCTs061180026
- Lead Sponsor
- ISOBE Takeshi
- Brief Summary
The PK of edoxaban were not markedly influenced by the combined administration with EGFR-TKI.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 12
1) Diagnosis of non-small cell lung cancer is attached by cytodiagnosis or tissue diagnosis.
2) EGFR gene mutation is positive, there is a possibility of single-agent treatment of gefitinib, erlotinib or afatinib.
3)ECOG PS 0-2.
4)Age over 20 years old.
5)It satisfies one of the following.
Non-small-cell lung cancer of stage IIIB or IV.
Reccurence of operation or concurrent chemoradiotherapy.
6)It is scheduled to oral administration or ingestion of 30 mg / day of Edoxaban.
7)6months or longer expected survival.
8)Written informed consent.
1)History of allergic reaction for edoxavan.
2)Severe renal dysfunction. (Ccr under 30 mL/min)
3)Severe liver disease.
4)Interstitial pneumonia.
5)Plannning for concurrent chemoradiotherapy.
6)Started medication or treatment for VTE.
7)More than 48 hours of anticoagulant (LMWH, UFH, fondaparinux or VKA etc) was administered to the most recently diagnosed VTE.
8)ALT is more than twice the facility reference value or T-Bil is more than 1.5 times the facility reference value.
9)Active bleeding.
10)Severe hypertention.
11)A pregnant woman, a woman in breast-feeding.
12)Taking aspirin or two kind os antiplatelet drug.
13)Acute infectious endocarditis.
14)An inappropriate case judged by doctor in charge.
15)In addition, the institution research director or the attending physician judged that administration of edoxaban was not appropriate.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic analysis.
- Secondary Outcome Measures
Name Time Method Presence or absence of symptomatic / asymptomatic VTE recurrence, onset of arterial thrombosis and hemorrhagic event for 6 months after starting administration of Edoxaban.