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Phase I Clinical Study of E7389
This study is ongoing, but not recruiting participants.
First Received: May 16, 2006   Last Updated: December 5, 2007   History of Changes
Sponsored by: Eisai Limited
Information provided by: Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00326950
  Purpose

To investigate primary object (dose limiting toxicity an maximum tolerated dose) and secondary objects (pharmacokinetics, safety, estimated of recommended dose, and anti-tumor effect in evaluable cases) of E7389 in patients with solid tumors by intravenously administering on Days 1 and 8 of a 21 day cycle.


Condition Intervention Phase
Cancer
Drug: E7389
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: E7389
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Phase I Clinical Study of E7389 in Patients With Solid Tumors

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:
  • Dose limiting toxicity (DLT), and maximum tolerated dose (MTD) [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: May 2006
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
1: Active Comparator Drug: E7389
E7389 intravenously administered on day 1 and 8 of a 21-day cycle.
2: Active Comparator Drug: E7389
E7389 intravenously administered on day 1 and 8 of a 21-day cycle.
3: Active Comparator Drug: E7389
E7389 intravenously administered on day 1 and 8 of a 21-day cycle.
4: Active Comparator Drug: E7389
E7389 intravenously administered on day 1 and 8 of a 21-day cycle.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 hospital from the start of the study drug treatment to 2weeks 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 in institute, unlessrelated to liver involvement by tumor, in which case

  • 5.0 times ULN (5) Alanine aminotransferase [ALT] 2.5 times the upper limits of normal in institute, unlessrelated to liver involvement by tumor, in which case
  • 5.0 times ULN (6) Total bilirubin 1.5 times the upper limits of normal in institute (7) Serum creatinine 1.5 times the upper limits of normal in institute (8) SpO2 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 (HBs) antigen.
  8. Patients who need continuous systemic steroid therapy during the study period
  9. Patients who need continuous use of phenitoin, carbamazepine, rifampicin and/or barbiturate which inducting 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326950

Locations
Japan, Chiba-prefecture
Kashiwa, Chiba-prefecture, Japan, 277-0882
Sponsors and Collaborators
Eisai Limited
Investigators
Study Director: Tomio Nakamura Eisai Limited
  More Information

No publications provided

Responsible Party: Eisai Company Limited ( Tomio Nakamura, Study Director )
Study ID Numbers: E7389-J081-105
Study First Received: May 16, 2006
Last Updated: December 5, 2007
ClinicalTrials.gov Identifier: NCT00326950     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Medical Research Inc.:
Cancer
Tumors
Phase I
E7389

ClinicalTrials.gov processed this record on May 07, 2009