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An Open Label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Previously Treated Subjects With Advanced Soft Tissue Sarcoma

Phase 2
20 Years
Open (Enrolling)
Soft Tissue Sarcoma

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Trial Information

An Open Label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Previously Treated Subjects With Advanced Soft Tissue Sarcoma

Inclusion Criteria

Inclusion Criteria

- Histologically or cytologically confirmed soft tissue sarcoma of high or intermediate

- Documented evidence of advanced or metastatic soft tissue sarcoma, not amenable to
surgery or radiotherapy

- Within 6 months from the radiographic evidence of disease progression by RECIST
criteria in the last chemotherapy regimen for advanced or metastatic soft tissue

- Presence of measurable disease by Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1

- Subjects who received at least one standard chemotherapy for advanced soft tissue
sarcoma (an anthracycline or an ifosfamide monotherapy, or a combination therapy)

- Subjects aged ≥ 20 years at the time of informed consent

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

- Adequate organ function

- Voluntary agreement to provide written informed consent

Exclusion Criteria

- A history of malignancies or recurrence within 5 years after the remission

- Significant cardiovascular impairment

- Any serious concomitant illness or infection requiring treatment.

- Hypersensitivity to either halichondrin B or halichondrin B chemical derivatives or

- Subjects who have previously participated in a study with eribulin (whether treated
with eribulin or not).

- Any medical or other condition which, in the opinion of the principal investigator,
will preclude participation in a clinical trial.

- Subjects who have received any anti-cancer therapy, including surgery, radiotherapy,
immunotherapy, cytotoxic, hormonal, biological (including humanized antibodies) and
targeted agents within 21 days, or any investigational agent within 30 days, prior to
the first dose of study drug.

- Subjects who have not recovered from toxicities as a result of prior anti-cancer
therapy to ≤ Grade 1, according to Common Terminology Criteria for Adverse Events
(CTCAE), except for peripheral neuropathy of Grade 2 and alopecia.

- Subjects with known cerebral metastases with clinical symptoms or requiring

- Pre-existing peripheral neuropathy > CTCAE Grade 2.

- Female subjects must not be pregnant with a negative by the pregnancy test at
Screening, or breastfeeding.

- Subjects participating in other clinical trials

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate the efficacy of eribulin, as measured by progression-free rate at 12 weeks (PFR 12 wks), in subjects with advanced soft tissue sarcoma, one of two subtypes: adipocytic [ADI] or leiomyosarcoma [LMS] previously treated with chemotherapy.

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Hiroshi Obaishi

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Co., Ltd.


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

November 2011

Completion Date:

January 2014

Related Keywords:

  • Soft Tissue Sarcoma
  • Soft Tissue Sarcoma
  • Sarcoma