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Phase I Trial of E7389 (Halichondrin B Analog) (NSC# 707389) in Patients With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Trial of E7389 (Halichondrin B Analog) (NSC# 707389) in Patients With Advanced Solid Tumors


I. To determine the maximum tolerated dose (MTD) of E7389 administered as an IV bolus over
1-2 minutes weekly for 3 weeks.

II. To describe the toxicities of E7389. III. To evaluate the pharmacokinetics of E7389. IV.
To determine the in vivo anti-mitotic activity of E7389 by cell cycle analysis and
immunohistochemistry in pre- and post-treatment tumor biopsies.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive E7389 IV over 1-2 minutes on days 1, 8, and 15. Treatment repeats every 4
weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of E7389 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients
experiences dose-limiting toxicity.

Inclusion Criteria:

- Advanced, histologically-confirmed solid tumors refractory to standard therapy or for
which no standard therapy exists

- Karnofsky performance status of at least 60% and estimated survival of at least two

- Serum creatinine =< 1.5 mg/dl or creatinine clearance >= 60 ml/min

- ANC >= 1,500/ul

- Platelets >= 100,000/ul

- Bilirubin =< 1.5 mg/dl

- SGOT and SGPT =< 2.5 times the upper limits of normal

- Prior to entry on study, a patient must be at least four weeks from prior
chemotherapy (six weeks from nitrosoureas, 8 weeks from UCN-01) and have recovered
from all side effects of prior therapy; there is no limit on the number of prior
chemotherapy regimens

- Written, voluntary, informed consent of the patient must be obtained in compliance
with institutional, state and federal guidelines

- Patients with brain metastases are INELIGIBLE for this study

- Due to concerns regarding possible drug interactions, patients with HIV taking
anti-retroviral medications are INELIGIBLE

- Pregnant patients and patients who are breast feeding are INELIGIBLE; all patients of
child-bearing potential, both male and female, must be advised to practice adequate
contraception; premenopausal women must have a negative pregnancy test prior to entry
on this study

- Patients with any non-malignant intercurrent illness (e.g. cardiovascular, pulmonary,
or central nervous system disease) which is either poorly controlled with currently
available treatment, or which is of such severity that the investigators deem it
inappropriate to treat the patient on this protocol are INELIGIBLE

- Patients currently being treated for a severe infection or who are recovering from
major surgery are INELIGIBLE until recovery is deemed complete by the investigators

- All patients must have evaluable disease; the presence of measurable disease is NOT
required for this phase I study; if unidimensionally measurable disease is present,
baseline measurements of up to 3 indicator lesions should be made no earlier than
four weeks prior to the first cycle of chemotherapy; pleural effusions, ascites and
bone metastases are not considered measurable

- CBC, differential count, platelet count, and blood chemistries should be done no
earlier than 72 hours prior to each cycle of chemotherapy

- Except for 4 weeks for tumor measurements and 72 hours for specified blood work,
pretreatment tests should be done no earlier than two weeks prior to the first cycle
of chemotherapy

- Once the MTD has been established, an additional10 patients will be accrued to obtain
pre- and post-treatment biopsy material in order to validate the molecular targets of
E7389 in man; therefore, to maximize likelihood of obtaining tissue from patients
treated in the expanded MTD cohort, only patients with tumors appropriate for
repeated biopsy are eligible during this stage of the study

Type of Study:


Study Design:

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

Outcome Measure:

MTD of eribulin mesylate defined as the highest dose tested in which no more than 1 of first 6 patients evaluated for toxicity experience dose-limiting toxicity (DLT) as assessed by NCI CTC version 2.0

Outcome Description:

Summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity, time of onset (i.e., course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and by cycle.

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Robert Morgan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2002

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neoplasms



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