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A Phase Ib Open-Label, Two-Arm, Dose-Finding Study of E7389 in Combination With Carboplatin in Patients With Solid Tumors

Phase 1
18 Years
Not Enrolling

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Trial Information

A Phase Ib Open-Label, Two-Arm, Dose-Finding Study of E7389 in Combination With Carboplatin in Patients With Solid Tumors

This is a Phase Ib open-label, two-arm, dose-finding study of E7389 in combination with
carboplatin in patients with solid tumors.

Inclusion Criteria:

1. Patients ≥ 18 years of age.

2. Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status score
of 0 or 1.

3. Patients with a life expectancy of ≥ three months.

4. Patients with adequate renal function as evidenced by serum creatinine ≤ 2.0 mg/dL or
calculated creatinine clearance ≥ 40 mL/min per the Cockcroft and Gault formula.

5. Patients with adequate bone marrow function as evidenced by absolute neutrophil count
(ANC) ≥ 1.5 × 10^9/L, hemoglobin ≥ 10.0 g/dL (this may have been corrected by
transfusion or growth factors) and platelet count ≥ 100 × 10^9/L.

6. Patients with adequate liver function as evidenced by bilirubin ≤ 1.5 mg/dL and
alkaline phosphatase (ALP), alanine transaminase (ALT) and aspartate aminotransferase
(AST) ≤ 3 times the upper limits of normal (ULN) (in the case of liver metastases ≤ 5
x ULN), unless there are bone metastases, in which case liver specific alkaline
phosphatase must be separated from the total and used to assess the liver function
instead of the total alkaline phosphatase. to assess the liver function instead of
the total alkaline phosphatase.

7. Patients willing and able to comply with the study protocol for the duration of the

8. Written informed consent prior to any study-specific screening procedures with the
understanding that the patient may withdraw consent at any time without prejudice.

For patients in the dose finding phase, the following additional inclusion criteria must
be fulfilled:

1. Patients with pathologically diagnosed, histologically or cytologically confirmed
advanced solid tumor, that has progressed following standard therapy or for which no
standard therapy exists (including surgery or radiation therapy).

2. Patients with disease progression despite standard therapy or have disease for which
no standard therapy exists.

3. Patients with ≤ Grade 2 chemotherapy or radiation-related toxicities except alopecia.

For NSCLC patients at the MTD, the following additional inclusion criteria must be

1. Patients with pathologically diagnosed, histologically or cytologically confirmed
advanced NSCLC (Stage IIIB or IV) with measurable disease, not amenable to surgical
or radiation treatment.

2. Patients with no prior chemotherapy for NSCLC including neoadjuvant or adjuvant

Exclusion Criteria:

1. Patients are excluded if they have received any of the following within three weeks
prior to first study treatment: investigational drugs, immunotherapy, gene therapy,
hormone therapy (except leuprolide, and megestrol acetate for appetite stimulation),
other biological therapy, chemotherapy or radiation. Patients with major surgery
without full recovery or major surgery within 3 weeks prior to first study treatment
are also excluded. Patients must have recovered from any previous major
therapy-related toxicity (Grade 3 or 4) to < Grade 2 at study entry (except for

2. Patients who have received radiation ≤ 3 weeks prior to study enrollment, whose
marrow exposure has exceeded 30% or who have not recovered from the toxic effects of
the treatment prior to study enrollment (except for alopecia).

3. Patients who have received prior high dose chemotherapy with hematopoietic stem cell
rescue or stem cell or bone marrow transplant in the past two years.

4. Patients with pulmonary lymphangitic involvement that results in pulmonary
dysfunction requiring active treatment, including the use of oxygen

5. Patients with active symptomatic brain metastases. Patients with central nervous
system (CNS) metastases are considered eligible if they have had adequately treated
brain metastases, ie, have completed treatment (tapered off steroids) at least four
weeks before starting treatment with E7389. Patients who have no evidence that the
metastases are symptomatic or actively growing (no evidence of midline shift on
computed tomography scan or magnetic resonance imaging) 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. It is not the intention of this study to treat patients
with active brain metastases.

6. Patients with meningeal carcinomatosis.

7. Patients who require therapeutic anti-coagulant therapy with warfarin or related

8. Women who are pregnant or breast-feeding. 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 (e.g., using 2 forms of
contraception including a barrier method). Perimenopausal women must be amenorrheic
for at least 12 months to be considered of non-childbearing potential.

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

10. Patients with severe/uncontrolled intercurrent illness or infection.

11. Patients with significant cardiovascular impairment (history of congestive heart
failure > New York Heart Association Grade II, unstable angina or myocardial
infarction within the past six months, or serious cardiac arrhythmia).

12. Patients with organ allografts.

13. Patients who have a history of positive testing for HIV and/or have active hepatitis
B or active hepatitis C at study entry.

14. Patients with pre-existing neuropathy > Grade 2.

15. Patients with a hypersensitivity to halichondrin B and/or to a halichondrin B
chemical derivative.

16. Patients who participated in a prior E7389 clinical trial.

17. Patients with other significant disease or disorders that, in the investigator's
opinion, would exclude the patient from the study.

For NSCLC patients at the MTD, the following additional exclusion criterion must be

1. Patients who have had a prior malignancy, other than carcinoma in situ of the cervix,
or non-melanoma skin cancer, unless the prior malignancy was diagnosed and definitively
treated ≥ five years previously with no subsequent evidence of recurrence.

Type of Study:


Study Design:

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

Outcome Measure:

Maximum Tolerated Dose (MTD) of Eribulin Mesylate of E7389 in Combination With Carboplatin in Subjects With Advanced Solid Tumors.

Outcome Description:

MTD was established by summarizing the number and percent of subject with dose- limiting toxicities (DLTs) for the first cycle.

Outcome Time Frame:

21 days (first cycle)

Safety Issue:


Principal Investigator

Eisai US Medical Services

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

October 2006

Completion Date:

Related Keywords:

  • Cancer



Albany, New York  12208
Hackensack, New Jersey  07601