Phase I Clinical Study of E7389

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00326950
• Date of registration: 16/05/2006
• Primary sponsor: Eisai Co., Ltd.
• Public title: Phase I Clinical Study of E7389
• Scientific title: Phase I Clinical Study of E7389 in Patients With Solid Tumors
• Date of first enrolment: June 2006
• Target sample size: 15
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00326950
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Japan

Contacts

• Name: Tomio Nakamura
• Affiliation: Eisai Co., Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:

1. Patients with histologically or cytologically confirmed solid tumors.

2. Patients who have progressed on or following standard therapy and with no other
treatment options.

3. Patients aged 20-74 when they give informed consent.

4. Patients having a performance status (PS) of Eastern Cooperative Oncology Group
(ECOG) 0 or 1.

5. Patients who can stay at the hospital from the start of the study drug treatment to 2
weeks of the first cycle.

6. Patients having adequate function of major organs (bone marrow, liver, kidney and
lungs):

(1) Neutrophil count 1,500/mm3 (2) Platelet count 100,000/mm3 (3) Hemoglobin 9.0 g/dL (4)
Aspartate aminotransferase [AST] 2.5 times the upper limits of normal (ULN) in institute,
unless related to liver involvement by tumor, in which case 5.0 times ULN (5) Alanine
aminotransferase [ALT] 2.5 times ULN in institute, unless related to liver involvement by
tumor, in which case 5.0 times ULN (6) Total bilirubin 1.5 times ULN in institute (7)
Serum creatinine 1.5 times ULN in institute (8) Pulse oximeter oxygen saturation 90%

7. Patients with no adverse drug reactions (excluding alopecia, etc.) that were caused by
the prior therapy or could influence the safety evaluation of the study drug.

The withdrawal periods required from the completion of the prior therapy to the start of
the study drug therapy are as follows:

1. Chemotherapy (excluding oral 5-FU and molecular target drugs), surgical therapy,
other study drugs: 4 weeks

2. Nitrosourea agents, mitomycin C: 6 weeks

3. Radiotherapy, endocrinotherapy, immunotherapy, oral 5-FU, molecular target drugs,
blood transfusion, blood products, G-CSF and other hematopoietic factors: 2 weeks

8. Patients who give written informed consent.

9. Patients with an expected survival of longer than 3 months from the start of the study
drug therapy.

Exclusion criteria:

1. Patients with systemic infection with a fever (38°C).

2. Patients with a large amount of pleural effusion, ascites and pericardial fluid
requiring drainage.

3. Patients with brain metastasis with clinical symptoms.

4. Patients with serious complications: (1) Patients with uncontrollable cardiac disease
such as ischemic heart disease and arrhythmia at a level of severity that needs to be
treated (excluding left ventricular hypertrophy, mild left ventricular volume
overload and mild right leg block that accompany hypertension) (2) Patients with
myocardial infarction within 6 months prior to study entry (3) Patients with a
complication of hepatic cirrhosis (4) Patients with interstitial pneumonia and
pulmonary fibrosis (5) Patients with a bleeding tendency

5. Women who are pregnant or breastfeeding, or premenopausal women of childbearing
potential.

Post-menopausal women must be amenorrheic for at least 12 months to be considered of
non-childbearing potential. Premenopausal women of childbearing potential with either
a positive pregnancy test at screening or no pregnancy test, or have not agreed to
use adequate measures of contraception.

6. Fertile men who are not willing to use contraception or fertile men with a female
partner who is not willing to use contraception.

7. Patients who have tested positive for human immunodeficiency virus (HIV), hepatitis C
virus (HCV) antibody, or hepatitis B virus surface antigen (HBsAg).

8. Patients who need continuous systemic steroid therapy during the study period.

9. Patients who need continuous use of phenytoin, carbamazepine, rifampicin and/or
barbiturate which induces cytochrome P450 (CYP3A4), a drug-metabolizing enzyme,
during the study period.

10. Patients who have received extensive radiation therapy (30% or more of bone marrow).

11. Patients who refused to receive a supportive therapy of blood transfusion by
suppressing bone marrow.

12. Patients who are participating in other clinical studies.

13. Patients whom the investigator or subinvestigator has judged inappropriate for this
study.



Age minimum: 20 Years
Age maximum: 74 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cancer

Intervention(s)

Drug: E7389

Primary Outcome(s)

Maximum Tolerated Dose (MTD) [Time Frame: 3 Weeks]

Number of Subjects Who Experienced Dose Limiting Toxicity (DLT) [Time Frame: 3 weeks]

Secondary Outcome(s)

Safety, Tolerability, the Pharmacokinetics, a Recommended Dose (RD) for Phase II Clinical Study and the Anti-tumor Effect in Evaluable Subjects. [Time Frame: 3 weeks]

Secondary ID(s)

E7389-J081-105

Source(s) of Monetary Support

Please refer to primary and secondary sponsors