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An Open-label, Multi-center, Phase 2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Previously Treated Subjects with Advanced Soft Tissue Sarcoma

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Soft Tissue Sarcoma
Date of first enrollment	01/11/2011
Target sample size	51
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : E7389 INN of investigational material : eribulin mesylate Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Administration of eribulin mesylate at a dose of 1.4 mg/m2 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

Outcome(s)

Primary Outcome

- To evaluate the efficacy of eribulin, as measured by progression-free rate at 12 weeks (PFR12wks), in subjects with advanced soft tissue sarcoma, one of two subtypes: adipocytic [ADI] or leiomyosarcoma [LMS] previously treated with chemotherapy. - To evaluate the efficacy of eribulin, as measured by PFR12wks in subjects advanced soft tissue sarcomas other than ADI/LMS previously treated with chemotherapy. Anti-tumor effects based on RECIST 1.1

Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include 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 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
Exclude criteria	- 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