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A Phase 2 Study of the Halichondrin B Analog E7389 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Previously Treated With a Taxane

Phase 2
18 Years
Not Enrolling
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

A Phase 2 Study of the Halichondrin B Analog E7389 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Previously Treated With a Taxane


I. Evaluate the antitumor activity of E7389 (eribulin mesylate), in terms of objective
response rate, in patients with recurrent or progressive stage IIIB or IV non-small cell
lung cancer.

II. Evaluate the time to progression and overall survival of patients treated with this

III. Evaluate the toxicity profile of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats
every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed once monthly for at least 6
months and then periodically thereafter.

Inclusion Criteria:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

- Stage IIIB or IV disease

- Recurrent or progressive disease

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral CT scan

- Must have received prior treatment with platinum-based therapy and a taxane

- Asymptomatic brain metastasis allowed provided off steroids for > 2 weeks

- Zubrod performance status (PS) ≤ 2 OR Karnofsky PS 60-100%

- Life expectancy > 3 months

- Platelet count ≥ 100,000/mm³

- Bilirubin ≤ 2.0 mg/dL

- AST/ALT ≤ 2.5 times upper limit of normal

- Creatinine normal OR creatinine clearance ≥ 50 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No neuropathy ≥ grade 2

- No uncontrolled illness including, but not limited to, any of the following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situations that would preclude study compliance

- No other concurrent investigational agents

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
and recovered

- At least 2 weeks since prior radiotherapy, including palliative radiotherapy, and

- No more than 2 prior chemotherapy regimens for NSCLC in the metastatic or adjuvant

- No concurrent combination antiretroviral therapy for HIV-positive patients

Exclusion Criteria:

- Absolute neutrophil count ≥ 1,500/mm³

- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to E7389

Type of Study:


Study Design:

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

Outcome Measure:

Objective response rate (CR or PR) according to RECIST criteria

Outcome Description:

Exact 95% confidence intervals will be calculated for this estimate (reflecting the interim analysis).

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Barbara Gitlitz

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

November 2006

Completion Date:

Related Keywords:

  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
City of Hope Duarte, California  91010