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A Phase II Study of the Halichondrin B Analog E7389 as Second Line Therapy for Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Adenocarcinoma of the Pancreas, Pancreatic Cancer, Recurrent Pancreatic Cancer, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer

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Trial Information

A Phase II Study of the Halichondrin B Analog E7389 as Second Line Therapy for Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer


I. To determine the objective response (complete and partial) to E7389 in patients with
locally advanced, unresectable, or metastatic pancreatic adenocarcinoma that progressed
after prior gemcitabine hydrochloride-based therapy.


I. To determine the antitumor activity of E7389, in terms of median survival, 1-year
survival rate, response or stable disease duration, toxicity, and time to disease
progression, in these patients.

OUTLINE: This is an open-label, multicenter study. Patients receive eribulin mesylate IV on
days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, all patients are followed at 4 weeks. Patients with
complete response, partial response, or stable disease are followed every 3 months.

Inclusion Criteria:

- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%.

- Life expectancy >= 3 months.

- Bilirubin =< 1.5 times upper limit of normal (ULN).

- AST and ALT =< 2.5 times ULN

- Creatinine normal or creatinine clearance >= 60 mL/min

- Not pregnant or nursing.

- Negative pregnancy test.

- No other active malignancies within the past 5 years except for cervical carcinoma in
situ or nonmelanomatous skin cancer.

- Recovered from prior therapy.

- At least 4 weeks since prior angiogenesis inhibitors and/or epidermal growth factor

- At least 4 weeks since prior major surgery.

- At least 4 weeks since prior fluorouracil or gemcitabine hydrochloride given
concurrently with radiotherapy as a radiosensitizer.

- At least 4 weeks since prior radiotherapy.

- No concurrent inhibitors or inducers of CYP3A4.

- Concurrent CYP3A4 substrates allowed.

- No other concurrent investigational agents.

- No concurrent combination antiretroviral therapy for HIV-positive patients.

- No other concurrent anticancer agents or therapies.

- No concurrent colony-stimulating factors during the first course of study therapy.

- Histologically or cytologically confirmed pancreatic adenocarcinoma that is locally
advanced, unresectable or metastatic. Disease progression must be documented if
patient underwent prior radiotherapy to local disease.

- Measurable disease, defined as >= 1 unidimesionally measurable lesion >= 20 mm by
conventional techniques or >= 10 mm by spiral CT scan.

- Evidence of disease progression after treatment with 1 line of prior gemcitabine
hydrochloride-based systemic therapy (single-agent or combination therapy) for
locally advanced or metastatic disease.

- No known brain metastases.

- Fertile patients must use effective contraception.

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

- No uncontrolled intercurrent 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.

- WBC >= 3,000/mm^3

- Absolute neutrophil count >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

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

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 (complete and partial) evaluated using RECIST criteria

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

Malcolm Moore

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network-Princess Margaret Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

August 2006

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Pancreas
  • Pancreatic Cancer
  • Recurrent Pancreatic Cancer
  • Stage II Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms