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)

NCT01458249 | Completed Phase 2 Results

• 1 other identifier: E7389-J081-217
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 12

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

Keywords

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Rate at 12 Weeks (PFR12wks)

  The PFR at 12 weeks was the percentage of participants with progression-free survival (success) measured as a binary variable based on the tumor response assessed at Week 12 after the start of study treatment. Participants were considered a success if one radiological evaluation performed at least Week 12 after start of therapy indicated stable disease (SD), or complete response (CR) or partial response (PR), as defined according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1); all other cases were considered as failures (including disease progression or death before the Week 12 evaluation, or had unknown disease status at Week 12). If new anticancer treatments were started before the Week 12 evaluation, participants were considered failures. A 2-sided 90% confidence interval (CI) was calculated using the exact method of binomial distribution.

  Week 12

Secondary Outcomes (7)

• Progression-Free Survival (PFS)

  Cycle 1 (Day 1) to progressive disease (PD) or death, or date of study cutoff (14 Nov 2014) up to 3 years

• Overall Survival (OS)

  Cycle 1 (Day 1) to death, or date of study cutoff, (14 Nov 2014), up to 3 years

• Objective Response Rate (ORR)

  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

• Disease Control Rate (DCR)

  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

• Clinical Benefit Rate (CBR)

  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

Study Arms (1)

eribulin mesylate 1.4 mg/m^2

EXPERIMENTAL

Drug: eribulin mesylate

Interventions

eribulin mesylate 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.

Also known as: E7389

eribulin mesylate 1.4 mg/m^2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (12)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Kashiwa, Chiba, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Hidaka, Hokkaido, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Tsu, Mie-ken, Japan

Location

Unknown Facility

Okayama, Okayama-ken, Japan

Location

Unknown Facility

Osaka, Osaka, Japan

Location

Unknown Facility

Suita, Osaka, Japan

Location

Unknown Facility

Bunkyo, Tokyo, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, Japan

Location

Unknown Facility

Shinjuku, Tokyo, Japan

Location

MeSH Terms

Conditions

Sarcoma

Interventions

eribulin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Sun Asami
• Organization: Eisai Co., Ltd.

+81-3-3817-5252

Study Officials

• Hiroshi Obaishi

  Eisai Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: October 24, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: February 1, 2016
• Last Updated: March 28, 2016
• Results First Posted: March 28, 2016

Record last verified: 2016-03

Locations

JP (12)