An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Previously Treated Subjects With Advanced or Metastatic Soft Tissue Sarcoma (Study E7389-J081-217)

Eisai

Status and phase

Completed

Phase 2

Conditions

Soft Tissue Sarcoma

Treatments

Drug: eribulin mesylate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01458249

E7389-J081-217

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy and safety of eribulin mesylate in subjects with soft tissue sarcoma who received at least one standard chemotherapy (an anthracycline or an ifosfamide monotherapy or a combination therapy).

Enrollment

52 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Histologically or cytologically confirmed soft tissue sarcoma of high or intermediate grade
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 sarcoma
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 both.
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 treatment.
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