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A Phase I Dose-Finding Study of E7389 (Halichondrin B Analog) in Patients With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling
Advanced Solid Tumors

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Trial Information

A Phase I Dose-Finding Study of E7389 (Halichondrin B Analog) in Patients With Advanced Solid Tumors

Inclusion Criteria

Inclusion Criteria

- Patients must have a histologically or cytologically confirmed and measurable
advanced solid tumor that has progressed following standard therapy or for which no
standard therapy exists (including surgery or radiation therapy)

- Patients may have received prior chemotherapy

- Patients must be aged > 18 years

- Patients must have a Karnofsky Performance Status of > 70%

- Patients must have a life expectancy of > 3 months

- Patients must have adequate renal function as evidenced by serum creatinine <1.5mg/dL
or creatinine clearance >= 45mL/minute

- Patients must have adequate bone marrow function as evidenced by absolute neutrophil
count > 1,500/µL and platelets > 100,000/µL

- Patients must have adequate liver function as evidenced by bilirubin < 1.5mg/dL and
alanine transaminase (ALAT) and aspartate transaminase (ASAT) <= 2 times the upper
limits of normal (ULN)unless related to liver involvement by tumor, in which case <=
5.0 times ULN

- Patients must be willing and able to comply with the study protocol for the duration
of the study

- Patients must give written informed consent prior to any study-specific screening
procedures with the understanding that the patient may withdraw consent at any time
without prejudice

Exclusion Criteria

- Patients who have received chemotherapy within three weeks (six weeks if nitrosoureas
were received) of E7389 treatment start

- Patients who have not recovered from any chemotherapy related or other therapy
related toxicity at study entry

- Patients who require active anti-coagulant therapy

- Women who are pregnant or breastfeeding. Women of childbearing potential with either
a positive pregnancy test at Screening or no pregnancy test. Women of childbearing
potential unless (1) surgically sterile or (2) using adequate measures of
contraception in the opinion of the Investigator (postmenopausal women must be
amenorrheic for at least 12 months to be considered of non-childbearing potential)

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

- Patients who have not successfully completed local therapy for previously treated
central nervous system (CNS) metastases and who have not been discontinued from
corticosteroids for at least four weeks before starting treatment with E7389.
Patients with asymptomatic brain metastases who have no evidence of midline shift on
CT scan or MRI may be enrolled without initiation of local therapy for the CNS
metastases. In this case, a repeat scan must be performed within four weeks of the
original scan to ensure that disease progression is not occurring.

- Patients who have tested positive for HIV

- Patients with severe uncontrolled intercurrent illness/infection (excluding

- Patients with uncontrolled cardiovascular illness defined as unstable angina,
myocardial infarction within 6 months prior to study entry, symptomatic congestive
heart failure (CHF) (NYHA II or higher) clinical evidence of CHF, or clinical
evidence of serious cardiac arrhythmia

- Patients with organ allografts

- Patients who have received investigational drugs, including immunotherapy, gene
therapy, hormone therapy, or other biologic therapy; anti-neoplastic therapy; or
radiation therapy (other than required for palliation) within three weeks of E7389
treatment start

- Patients who have had major surgery within four weeks of E7389 treatment start
without a full recovery

- Patients with a hypersensitivity to Halichondrin B and/or Halichondrin B-like

- Patients with other significant disease that, in the Investigator's opinion, would
exclude the patient from the study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of the Maximum Tolerated Dose

Outcome Time Frame:

28 Days

Safety Issue:


Principal Investigator

Dale Shuster, Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

September 2003

Completion Date:

July 2005

Related Keywords:

  • Advanced Solid Tumors
  • Metastatic Tumors
  • Advanced Solid Tumors
  • Stage IV Tumors
  • Solid Tumors
  • Recurrent Solid Tumors
  • Neoplasms



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