Pharmacokinetic Study of E7080/Lenvatinib in Chinese Subjects With Solid Tumor

Eisai

Status and phase: Completed; Phase 1

Conditions: Solid Tumor

Treatments: Drug: lenvatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03009292

E7080-C086-108

Details and patient eligibility

About

Study E7080-C086-108 is an open-label, single- and multiple-dose pharmacokinetic (PK) study of lenvatinib (administered orally, once a day [QD]) in Chinese participants with solid tumor. A total of 12 participants will be enrolled to evaluate the PK of 24 milligrams (mg) QD dosing of lenvatinib.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with a histological and/or cytological diagnosis of solid tumor

• Participants with solid tumor that is resistant to standard anti-tumor therapies, or for which no appropriate treatment is available

• Participants whose toxicity of previous treatment has recovered to Grade 1 or lower (except for alopecia)

• Participants who have completed previous anti-tumor therapy (such as surgery, radiotherapy) at least 4 weeks before treatment

• Participants who are 18 years or older at the time of obtaining informed consent

• Participants with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1

• Participants who meet all of the following items:

  • Hemoglobin ≥9.0 grams per deciliter (g/dL)
  • Neutrophil count ≥1.5×10^3/microliters (µL)
  • Platelet count ≥10×10^4/µL
  • Total bilirubin ≤1.8 milligrams (mg)/dL
  • Aspartate aminotransferase (AST) ≤100 International Units per liter (IU/L)
  • Alanine aminotransferase (ALT) ≤100 IU/L
  • Serum creatinine ≤1.5 mg/dL or creatinine clearance ≥50 milliliters per minute (mL/min). Creatinine clearance will be calculated based on Cockcroft-Gault method using the following formula: Male: (140-age) × weight ÷ (serum creatinine × 72); Female: 0.85 × (140-age) × weight ÷ (serum creatinine × 72).

• Participants expected to survive for 12 weeks or longer

• Males and females of childbearing potential must agree to use appropriate contraception from the giving of consent to 30 days after study drug administration. Female participants of childbearing potential must test negative for pregnancy at screening

• Participants who voluntarily agree to participate in this study in writing

Exclusion criteria

• Participants with brain metastasis accompanied by clinical symptoms or requiring treatment

• Participants with the following complications or medical history

  1. Systemic severe infections requiring medical treatment

  2. The following cardiovascular diseases

     1. Ischemic cardiac disease or arrhythmia requiring medical treatment
     2. Angina pectoris or myocardial infarction within 24 weeks before enrollment
     3. Corrected QT interval (QTc) greater than 480 milliseconds (msec) (Fridericia's method)

  3. Hemoptysis (fresh blood) ≥ 1/2 teaspoon (2.5 mL) or clinically significant hemorrhagic or thrombotic events within 4 weeks before enrollment

  4. Systolic pressure ≥150 millimeters of mercury (mmHg) and diastolic pressure ≥90 mmHg

  5. If proteinuria is ≥2+ in a qualitative test for urine protein, ≥1.0 grams for 24 hours is accumulated

  6. Complications or surgery (such as malabsorption syndrome, chronic diarrhea, or total gastrectomy) that could significantly influence the absorption of the investigational drug

  7. Have undergone major surgery within 4 weeks before enrollment

  8. Co-existing effusion requiring treatment

• Participants unable to take oral medication

• Participants scheduled for surgery during the projected course of the study

• Participants who test positive for human immunodeficiency virus (HIV antibody), or positive for hepatitis B surface (HBs antigen) or hepatitis C virus (HCV antibody)

• Participants who have taken lenvatinib before

• Participants who in the view of the principal investigator or sub-investigator are not able to comply with this protocol because of psychiatric or physical diseases including alcoholism or drug addiction

• Pregnant or nursing participants

• Participants who are participating in another clinical trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

24 mg lenvatinib

Experimental group

Description:

Participants will receive once daily oral dosing of lenvatinib 24 milligrams (mg)

Treatment:

Drug: lenvatinib