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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01458249
First received: October 21, 2011
Last updated: January 21, 2013
Last verified: January 2013
  Purpose

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).


Condition Intervention Phase
Soft Tissue Sarcoma
Drug: E7389
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 51
Study Start Date: November 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: eribulin mesylate 1.4 mg/m^2 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458249

Locations
Japan
Nagoya, Aichi, Japan
Kashiwa, Chiba, Japan
Hidaka, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Tsu, Mie, Japan
Suita, Osaka, Japan
Bunkyo, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Shinjuku, Tokyo, Japan
Fukuoka, Japan
Okayama, Japan
Osaka, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Hiroshi Obaishi Eisai Co., Ltd.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01458249     History of Changes
Other Study ID Numbers: E7389-J081-217
Study First Received: October 21, 2011
Last Updated: January 21, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Soft Tissue Sarcoma

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014