An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors
Condition: Cancer: Solid Tumors
MeSH terms: Neoplasms
Intervention: E7080
Intervention description: E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
Intervention MeSH terms: Lenvatinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Cancer, solid tumors

Summary:

      The purpose of this study is to determine the maximum tolerable dose (MTD) and the related
      effects of E7080 administered to patients with solid tumors that are resistant to approved
      existing anti-tumor therapies, or for which no appropriate treatment is available.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients who have histologically and/or cytologically confirmed solid tumors requiring
             treatment.

          2. Patients with solid tumors which are resistant to approved conventional anti-tumor
             therapies, or for which no appropriate treatment is available.

          3. Patients who had completed all previous treatments (including surgery and
             radiotherapy) and supportive care (such as transfusion of blood, blood components and
             granulocyte colony-stimulating factor [G-CSF] treatment) at least 4 weeks before
             registration, and no sign or symptom of acute toxicity occurred in previous
             treatments.

          4. Patients 20 years or older and less than 75 years of age at the time of registration.

          5. Patients with 0 or 1 Performance Status (PS) established by Eastern Cooperative
             Oncology Group (ECOG.)

          6. Patients who can stay in hospital for more than 1 cycle of treatment.

          7. Patients who are expected to survive for more than 3 months from the start of study
             drug administration.

          8. Patients who have provided written informed consent for the participation in the
             study.

        Exclusion criteria:

          1. Patients with clinical symptoms due to brain metastases requiring treatment.

          2. Patients who have any of the following laboratory test findings:

               1. Hemoglobin less than 9.0 g/dL

               2. Neutrophil count less than 1.5 x 10 9/L

               3. Platelet count less than 100 x 10 9/L

               4. Serum bilirubin greater than 1.5 mg/dL

               5. AST, ALT greater than 100 IU/L

               6. Serum creatinine greater than 1.5 mg/dL or creatinine clearance less than 50
                  mL/minute

          3. Patients with positive reaction for human immunodeficiency virus (HIV) or hepatitis
             virus C (HCV) antibody or hepatitis B virus surface (HBs) antigen, or patients with
             untreated serious infections.

          4. Patients with clinically significant cardiac disorders or unstable ischemic heart
             diseases including myocardial infarction within six months before the registration for
             the study.

          5. Patients with marked Baseline prolongation of QT/QTc interval (QTc interval greater
             than 450 msec for males or greater than 470 msec for females) using the Fridericia
             method for QTc analysis.

          6. Patients with hemorrhagic or thrombotic diseases or who are using therapeutic doses of
             anticoagulants such as aspirin, warfarin, or ticlopidine.

          7. Patients who are diagnosed with hypertension (defined as repeatedly measured blood
             pressure = 160/90 mmHg) at Screening, irrespective of use of antihypertensive drugs.

          8. Patients who have proteinuria greater than 1 on bedside testing.

          9. Patients who have history of insufficient gastrointestinal absorption, or patients who
             received gastric or intestinal anastomoses within 4 weeks before registration.

         10. Patients who have history of alcoholism, drug addiction or mental or physical
             disorders, which, in the investigators opinion, may impair study compliance.

         11. Patients who received any investigational drug within 30 days before the registration
             of the study.

         12. Patients who received CYP3A4 inhibitors including itraconazole, erythromycin,
             clarithromycin, diltiazem or verapamil during screening and who have to use these
             drugs during the study.

         13. Pregnant or nursing patients (all female patients with pregnancy potential must have
             negative pregnancy test performed before registration, and post-menopausal women must
             be amenorrheic for at least 12 months.) Female patients must use appropriate
             contraception.

         14. Fertile male patients who refuse to use contraception, or whose female partners are
             not using appropriate contraception.

         15. Patients who are judged by the investigator to be inappropriate for the study.