Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma
A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma
2 other identifiers
interventional
452
22 countries
116
Brief Summary
This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of eribulin with dacarbazine in subjects with advanced soft tissue sarcoma who have disease progression within 6 months prior to study enrolment following standard therapies which must have included an anthracycline, unless contraindicated and then at least one additional regimen after failure of the anthracycline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2011
Longer than P75 for phase_3
116 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2011
CompletedFirst Submitted
Initial submission to the registry
March 31, 2011
CompletedFirst Posted
Study publicly available on registry
April 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2016
CompletedResults Posted
Study results publicly available
February 28, 2017
CompletedJune 22, 2023
February 1, 2018
3.8 years
March 31, 2011
January 6, 2017
June 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
OS was defined as the time in months from the date of treatment start until death, regardless of cause. In the absence of confirmation of death, participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. Participants who died on the date of randomization had a survival time of 0.5 day. Allocation of randomization numbers were performed based upon the following stratification factors: (a) Histology (adipocytic \[ADI\] or leiomyosarcoma \[LMS\]), (b) Region (Region 1: USA and Canada; or Region 2: Western Europe, Australia, Israel; or Region 3: Eastern Europe, Latin America, and Asia), and (c) Number of prior regimens for advanced soft tissue sarcoma (STS) (2 or greater than \[\>\] 2 prior regimens).
From date of treatment start until date of death from any cause, up to 5 years 5 months
Secondary Outcomes (3)
Progression-Free Survival (PFS)
Randomization (day 1) to the date of first documentation of disease progression, or date of death (whichever occurred first), up to 5 years 5 months
Progression-Free Rate at 12 Weeks (PFR12wks)
From date of randomization start until Week 12
Clinical Benefit Rate (CBR)
From date of treatment start (Day 1) until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, up to 5 years 5 months
Study Arms (2)
Arm A
EXPERIMENTALArm B
ACTIVE COMPARATORInterventions
Administration of eribulin mesylate at a dose of 1.4 mg/m\^2 as an intravenous (IV) bolus infusion over 2-5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days.
Administration of dacarbazine at a dose of 850 mg/m\^2, or 1,000 mg/m\^2, or 1,200 mg/m\^2 selected by the Principal Investigator \[PI\] or designee according to the subject's clinical status as an IV infusion over 15-30 minutes on Day 1 of every cycle, where the duration of each cycle is 21 days.
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of soft tissue sarcoma of high or intermediate grade with one of the following histological subtypes:
- Adipocytic sarcoma, including:
- Dedifferentiated
- Myxoid
- Round Cell
- Pleomorphic - Leiomyosarcoma
- Subjects should have received at least two standard systematic regimens for advanced soft tissue sarcoma one of which must have included an anthracycline (unless contraindicated).
- Radiographic evidence of disease progression by RECIST criteria on or after the last anti-cancer therapy within the 6 months prior to randomization.
- Presence of measurable disease meeting the following criteria:
- At least one lesion of greater than or equal to 1.0 cm in long-axis diameter for non lymph nodes or greater than or equal to 1.5 cm in short-axis diameter for lymph nodes which is serially measurable according to RECIST 1.1 using either computerized tomography or magnetic resonance imaging or panoramic and close-up color photography.
- Lesions that have had radiotherapy must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.
- Eastern Cooperative Oncology Group, performance status of 0, 1 or 2.
- Adequate renal function defined as calculated creatinine clearance greater than 50 mL/min per the Cockroft and Gault formula.
- Adequate bone marrow function, defined as:
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mm3 or greater than or equal to 1.5 x 10\^9/L.
- +13 more criteria
You may not qualify if:
- Subjects who have received any anti-cancer therapy, including radiotherapy, cytotoxic, hormonal, biological (including humanized antibodies) and targeted agents within 21 days, or five half-lives of the drug (whichever is longer) prior to randomization.
- Subjects that have previously been treated with dacarbazine or its analogue temozolomide or eribulin.
- Major surgery within 21 days prior to randomization.
- Pre-existing peripheral neuropathy greater than CTCAE Grade 2.
- Significant cardiovascular impairment, defined as:
- Cardiac failure, New York Heart Association (NYHA) Class II according to the NYHA Functional Classification,
- Unstable angina or myocardial infarction within 6 months of enrolment,
- Serious and potentially life-threatening arrhythmia.
- Subjects with a high probability of Long QT Syndrome or QTc interval prolongation of more than or equal to 501 msec on at least two separate ECGs, following correction of any electrolyte imbalance.
- Subjects with known central nervous system metastases.
- Any serious concomitant illness or infectious disease requiring treatment, or infectious disease not requiring treatment, but with significant risks for myelosuppressive complications associated with chemotherapy.
- Any malignancy that required treatment, or has shown evidence of recurrence (except for soft tissue sarcoma, non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ) during the 5 years prior to randomization.
- Female subjects must not be pregnant as documented by a negative beta-human chorionic gonadotropin (beta-hCG) test with a minimum sensitivity 25 IU/L or equivalent unit of beta-hCG at Screening and Baseline, or breastfeeding.
- Hypersensitivity to the active substance, or any of the excipients of the eribulin drug product, or dacarbazine, (please refer to the dacarbazine prescribing information).
- Any medical or other condition which, in the opinion of the PI or designee, will preclude participation in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (119)
Unknown Facility
Tucson, Arizona, United States
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Los Angeles, California, United States
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Orange, California, United States
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Santa Monica, California, United States
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Stanford, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Post Falls, Idaho, United States
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Chicago, Illinois, United States
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Park Ridge, Illinois, United States
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Urbana, Illinois, United States
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Iowa City, Iowa, United States
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Boston, Massachusetts, United States
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St Louis, Missouri, United States
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Newark, New Jersey, United States
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Buffalo, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Durham, North Carolina, United States
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Cleveland, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Houston, Texas, United States
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Burlington, Vermont, United States
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Seattle, Washington, United States
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Ciudad de Buenos Aires, Argentina
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San Miguel de Tucumán, Argentina
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San Salvador de Jujuy, Argentina
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Camperdown, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Woolloongabba, Queensland, Australia
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Woodville South, South Australia, Australia
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Nedlands, Western Australia, Australia
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Graz, Austria
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Salzburg, Austria
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Vienna, Austria
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Brussels, Belgium
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Leuven, Belgium
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Liège, Belgium
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Porto Alegre, Rio Grande do Sul, Brazil
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Florianópolis, Santa Catarina, Brazil
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Barretos, Brazil
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Curitiba, Brazil
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Jaú, Brazil
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Porto Alegre, Brazil
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Salvador, Brazil
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São Paulo, Brazil
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Brno, Czechia
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Hradec Králové, Czechia
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Nový Jičín, Czechia
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Prague, Czechia
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Herlev, Denmark
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Angers, France
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Bordeaux, France
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Lyon, France
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Marseille, France
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Nantes, France
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Paris, France
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Poitiers, France
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Saint-Priest-en-Jarez, France
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Villejuif, France
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Berlin, Germany
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Cologne, Germany
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Dresden, Germany
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Essen, Germany
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Hanover, Germany
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Mannheim, Germany
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Tübingen, Germany
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Haifa, Israel
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Jerusalem, Israel
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Ramat Gan, Israel
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Tel Aviv, Israel
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Aviano, Pordenone, Italy
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Candiolo, Italy
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Milan, Italy
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Monza, Italy
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Padua, Italy
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Rozzano (MI), Italy
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Torino, Italy
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Amsterdam, Netherlands
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Leiden, Netherlands
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Christchurch, New Zealand
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Gdansk, Poland
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Gliwice, Poland
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Warsaw, Poland
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Cluj-Napoca, Romania
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Craiova, Romania
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Iași, Romania
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Sibiu, Romania
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Chelyabinsk, Russia
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Kazan', Russia
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Moscow, Russia
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Obninsk, Russia
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Singapore, Singapore
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Daejeon, South Korea
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Seongnam, South Korea
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Seoul, South Korea
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Palma de Mallorca, Balearic Islands, Spain
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Badalona, Catalonia, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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Madrid, Madrid, Spain
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Barcelona, Spain
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Valencia, Spain
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Hat Yai, Changwat Songkhla, Thailand
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Bangkok, Thailand
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Chiang Mai, Thailand
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Pathum Wan, Thailand
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Glasgow, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Swansea, United Kingdom
Related Publications (1)
Schoffski P, Chawla S, Maki RG, Italiano A, Gelderblom H, Choy E, Grignani G, Camargo V, Bauer S, Rha SY, Blay JY, Hohenberger P, D'Adamo D, Guo M, Chmielowski B, Le Cesne A, Demetri GD, Patel SR. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016 Apr 16;387(10028):1629-37. doi: 10.1016/S0140-6736(15)01283-0. Epub 2016 Feb 10.
PMID: 26874885DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eisai Medical Information
- Organization
- Eisai Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2011
First Posted
April 4, 2011
Study Start
March 10, 2011
Primary Completion
January 2, 2015
Study Completion
August 10, 2016
Last Updated
June 22, 2023
Results First Posted
February 28, 2017
Record last verified: 2018-02