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 (Study E7389-J081-217)

Soft Tissue Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01458249
• Other study ID #: E7389-J081-217
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 21, 2011
• Last updated: July 16, 2014
• Start date: November 2011
• Est. completion date: April 2016

Study information

• Verified date: July 2014
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Drug:
• E7389
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 weeks	No
Primary	To evaluate the efficacy of eribulin, as measured by PFR 12 wks in subjects advanced soft tissue sarcomas other than ADI/LMS previously treated with chemotherapy.		12 weeks	No