Clinical trial NCT01458249: 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)
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Soft Tissue Sarcoma
Keywords: Soft Tissue Sarcoma
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-10-24
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Progression-free Rate at 12 Weeks (PFR12wks)
timeFrame: Week 12
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Cycle 1 (Day 1) to progressive disease (PD) or death, or date of study cutoff (14 Nov 2014) up to 3 years
measure: Overall Survival (OS)
timeFrame: Cycle 1 (Day 1) to death, or date of study cutoff, (14 Nov 2014), up to 3 years
measure: Objective Response Rate (ORR)
timeFrame: Date of CR or PR to the date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years
measure: Disease Control Rate (DCR)
timeFrame: Date of CR, PR, or SD to date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years
measure: Clinical Benefit Rate (CBR)
timeFrame: First dose of study treatment to the date of CR, PR, or dSD to date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years
measure: Durable Stable Disease (SD) Rate (dSDR)
timeFrame: Date of dSD to date of PD or death, whichever is first, or date of study cutoff (24 Nov 2014), up to 3 years
measure: Best Overall Response (BOR)
timeFrame: Date of CR, PR, SD to PD or death of any cause, whichever is first, or date of study cutoff (14 Nov 2014), or up to 3 years
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Kashiwa
country: Japan
state: Chiba
city: Hidaka
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Tsu
country: Japan
state: Mie
city: Suita
country: Japan
state: Osaka
city: Bunkyo
country: Japan
state: Tokyo
city: Chuo-ku
country: Japan
state: Tokyo
city: Shinjuku
country: Japan
state: Tokyo
city: Fukuoka
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
Study officials:
affiliation: Eisai Co., Ltd.
name: Hiroshi Obaishi
role: STUDY_DIRECTOR
References: