A pharmacokinetics study of edoxaban in non-small cell lung cancer patients harboring EGFR mutation.

JRCT ID: jRCTs061180026

Registered date:20/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 16/08/2016
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Blood sampling

Outcome(s)

• Primary Outcome: Pharmacokinetic analysis.
• Secondary Outcome: Presence or absence of symptomatic / asymptomatic VTE recurrence, onset of arterial thrombosis and hemorrhagic event for 6 months after starting administration of Edoxaban.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: ISOBE Takeshi
• Source(s) of Monetary Support: Daiichi Sankyo Company, Limited,Daiichi Sankyo Company, Limited
• Secondary ID(s): UMIN000021160