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)

NCT ID: NCT01458249

Last Updated: 2016-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2016-02-29

Brief Summary

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).

Conditions

Soft Tissue Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

eribulin mesylate 1.4 mg/m^2

Group Type: EXPERIMENTAL

eribulin mesylate

Intervention Type: DRUG

Administration of eribulin mesylate at a dose of 1.4 mg/m\^2 as an IV bolus infusion over 2-5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days.

Interventions

eribulin mesylate

Administration of eribulin mesylate at a dose of 1.4 mg/m\^2 as an IV bolus infusion over 2-5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days.

Intervention Type: DRUG

Other Intervention Names

E7389

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hiroshi Obaishi

Role: STUDY_DIRECTOR

Eisai Co., Ltd.

Locations

Nagoya, Aichi-ken, Japan

Kashiwa, Chiba, Japan

Fukuoka, Fukuoka, Japan

Hidaka, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Tsu, Mie-ken, Japan

Okayama, Okayama-ken, Japan

Osaka, Osaka, Japan

Suita, Osaka, Japan

Bunkyo, Tokyo, Japan

Chuo-ku, Tokyo, Japan

Shinjuku, Tokyo, Japan

Countries

Japan

Other Identifiers

E7389-J081-217

Identifier Type: -

Identifier Source: org_study_id