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Soft Tissue SarcomaPhase 3NCT01327885

Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma

A Phase 3 study testing Eribulin mesylate 1.4 mg/m^2 intravenous and Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IV in people with Soft Tissue Sarcoma, run by Eisai Inc. at 119 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
Eribulin mesylate 1.4 mg/m^2 intravenous and Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IV
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
452 participants
Where
119 sitesin 23 countries
Study dates
10 Mar 2011to 10 Aug 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • Documented evidence of advanced (locally recurrent, locally advanced and/or metastatic) adipocytic (restricted to subtypes listed in Inclusion 1) or leiomyosarcoma, incurable by surgery and/or radiotherapy.
  • 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.
  • Platelet count greater than or equal to 100,000/mm3 or greater than or equal to 100 x 10^9/L.
  • Hemoglobin (Hb) greater than or equal to 10g/dL at baseline (blood transfusions,hematopoietic growth factors and hematinics are allowed during the Prerandomization Phase to correct Hb values less than 10g/dL).
  • Adequate liver function, defined as:
  • Bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome.
  • Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 times ULN. For total ALP greater than 3 times ULN, the ALP liver isoenzyme must be less than or equal to 3 times ULN.
  • All female subjects will be considered to be of child-bearing potential unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically (i.e., bilateral tubal ligation greater than or equal to 1 menstrual cycle prior to randomization, or have undergone a hysterectomy and/or bilateral oophorectomy).
  • Female subjects of child-bearing potential must agree to use two forms of highly effective contraception from the last menstrual period prior to randomization (or use a double barrier method as described below until they are on two forms of highly effective contraception for at least one menstrual cycle), during the study treatment, and for 3 months after the final dose of study treatment. Female subjects exempt from this requirement are subjects who practice total abstinence. If currently abstinent, the subject must agree to use a double barrier method of contraception, i.e., condom and occlusive cap (diaphragm or cervical/vault caps) with spermicide or until they are on two forms of highly effective contraception for at least one menstrual cycle if they become sexually active during the study treatment and for 3 months after the final dose of study treatment. Highly effective contraception includes:
  • Placement of intrauterine device or system,
  • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault cap) with spermicide,
  • Established hormonal contraceptive methods: oral, injectable or implant. Female subjects who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product from the last menstrual period prior to randomization, and must continue to use the same hormonal contraceptive product during study treatment, and for 3 months after the first dose of study treatment.
  • Vasectomized partner with confirmed azoospermia.
  • Male subjects and their female partner who are of child-bearing potential (as defined in Inclusion 10), and are not practicing total abstinence, must agree to use two forms of highly effective contraception from the last menstrual period of their female partner prior to randomization (or use a double barrier method as described above until they are on two forms of highly effective contraception for at least one menstrual cycle), during study treatment, and for 3 months (or 6 months if they received dacarbazine) after the final dose of study treatment. If currently abstinent, must agree to use a double barrier method of contraception if they become sexually active, or until they are on two forms of highly effective contraception as described above.
  • Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
  • Males or females aged greater than or equal to 18 years at the time of informed consent.

Who cannot join

  • 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 who have not recovered from acute toxicities as a result of prior anti-cancer therapy to less than or equal to Grade 1, according to Common Terminology Criteria for Adverse Events (CTCAE), except for peripheral neuropathy (see Exclusion 6) and alopecia.
  • 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:
Show all 16Show fewer
  • 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.

Trial locations and contacts

119 sites in 23 countries.

119 sites in 23 countries

United States30 sites

  • Study site

    Atlanta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Boston, Massachusetts

  • Study site

    Buffalo, New York

  • Study site

    Burlington, Vermont

  • Study site

    Chicago, Illinois

  • Study site

    Cleveland, Ohio

  • Study site

    Denver, Colorado

  • Study site

    Durham, North Carolina

  • Study site

    Houston, Texas

  • Study site

    Iowa City, Iowa

  • Study site

    Los Angeles, California

  • Study site

    New York, New York

  • Study site

    Newark, Delaware

  • Study site

    Newark, New Jersey

  • Study site

    Orange, California

  • Study site

    Park Ridge, Illinois

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Post Falls, Idaho

  • Study site

    Rochester, New York

  • Study site

    Santa Monica, California

  • Study site

    Seattle, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Stanford, California

  • Study site

    Tampa, Florida

  • Study site

    Tucson, Arizona

  • Study site

    Urbana, Illinois

  • Study site

    Washington D.C., District of Columbia

Other trials in United States

France9 sites

  • Study site

    Angers

  • Study site

    Bordeaux

  • Study site

    Lyon

  • Study site

    Marseille

  • Study site

    Nantes

  • Study site

    Paris

  • Study site

    Poitiers

  • Study site

    Saint-Priest-en-Jarez

  • Study site

    Villejuif

Other trials in France

Brazil8 sites

  • Study site

    Barretos

  • Study site

    Curitiba

  • Study site

    Florianópolis, Santa Catarina

  • Study site

    Jaú

  • Study site

    Porto Alegre, Rio Grande do Sul

  • Study site

    Porto Alegre

  • Study site

    Salvador

  • Study site

    São Paulo

Other trials in Brazil

Germany7 sites

  • Study site

    Berlin

  • Study site

    Cologne

  • Study site

    Dresden

  • Study site

    Essen

  • Study site

    Hanover

  • Study site

    Mannheim

  • Study site

    Tübingen

Other trials in Germany

Italy7 sites

  • Study site

    Aviano, Pordenone

  • Study site

    Candiolo

  • Study site

    Milan

  • Study site

    Monza

  • Study site

    Padova

  • Study site

    Rozzano (MI)

  • Study site

    Torino

Other trials in Italy

Spain6 sites

  • Study site

    Badalona, Catalonia

  • Study site

    Barcelona

  • Study site

    L'Hospitalet de Llobregat, Catalonia

  • Study site

    Madrid, Madrid

  • Study site

    Palma de Mallorca, Balearic Islands

  • Study site

    Valencia

Other trials in Spain

Australia5 sites

  • Study site

    Camperdown, New South Wales

  • Study site

    Nedlands, Western Australia

  • Study site

    St Leonards, New South Wales

  • Study site

    Woodville South, South Australia

  • Study site

    Woolloongabba, Queensland

Other trials in Australia

Czechia4 sites

  • Study site

    Brno

  • Study site

    Hradec Králové

  • Study site

    Nový Jičín

  • Study site

    Prague

Other trials in Czechia

Israel4 sites

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Ramat Gan

  • Study site

    Tel Aviv

Other trials in Israel

Romania4 sites

  • Study site

    Cluj-Napoca

  • Study site

    Craiova

  • Study site

    Iași

  • Study site

    Sibiu

Other trials in Romania

Russia4 sites

  • Study site

    Chelyabinsk

  • Study site

    Kazan'

  • Study site

    Moscow

  • Study site

    Obninsk

Other trials in Russia

Thailand4 sites

  • Study site

    Bangkok

  • Study site

    Chiang Mai

  • Study site

    Hat Yai, Changwat Songkhla

  • Study site

    Pathum Wan

Other trials in Thailand

United Kingdom4 sites

  • Study site

    Glasgow

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Swansea

Other trials in United Kingdom

Argentina3 sites

  • Study site

    Ciudad de Buenos Aires

  • Study site

    San Miguel de Tucumán

  • Study site

    San Salvador de Jujuy

Other trials in Argentina

Austria3 sites

  • Study site

    Graz

  • Study site

    Salzburg

  • Study site

    Vienna

Other trials in Austria

Belgium3 sites

  • Study site

    Brussels

  • Study site

    Leuven

  • Study site

    Liège

Other trials in Belgium

Canada3 sites

  • Study site

    Montreal, Quebec

  • Study site

    Ottawa, Ontario

  • Study site

    Toronto, Ontario

Other trials in Canada

Poland3 sites

  • Study site

    Gdansk

  • Study site

    Gliwice

  • Study site

    Warsaw

Other trials in Poland

South Korea3 sites

  • Study site

    Daejeon

  • Study site

    Seongnam

  • Study site

    Seoul

Other trials in South Korea

Netherlands2 sites

  • Study site

    Amsterdam

  • Study site

    Leiden

Other trials in Netherlands

Denmark1 site

  • Study site

    Herlev

Other trials in Denmark

New Zealand1 site

  • Study site

    Christchurch

Other trials in New Zealand

Singapore1 site

  • Study site

    Singapore

Other trials in Singapore

About this study

Official title: A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma

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.

Being tested
Eribulin mesylate 1.4 mg/m^2 intravenous, Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IV
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eribulin mesylate 1.4 mg/m^2 intravenousDrug

    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.

  • Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IVDrug

    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.

Study groups in NCT01327885
Study groupRoleWhat they receive
Arm AExperimentalNot described
Receives: Drug: Eribulin mesylate 1.4 mg/m^2 intravenous
Arm BActive comparatorNot described
Receives: Drug: Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IV

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: From date of treatment start until date of death from any cause, up to 5 years 5 months

Secondary outcomes (3)

  1. Progression-Free Survival (PFS)

    PFS was defined as the time from the date of randomization to the date of first documentation of disease progression, or date of death (whichever occurred first). The date of disease progression was defined as the date of radiologic disease progression as assessed by the investigator or designee based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Participants who did not have an event (i.e., participants who were lost to follow-up or who did not progress or die at the date of data cut-off), were censored. Participants who discontinued study treatment without disease progression were censored on the date of their last radiological assessment (scan date).

    Measured: 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

  2. Progression-Free Rate at 12 Weeks (PFR12wks)

    The PFR12wks was defined as the percentage of participants who were still alive without disease progression at 12 weeks from the date of randomization. Tumor assessment by the investigator or designee was based on RECIST criteria 1.1.

    Measured: From date of randomization start until Week 12

  3. Clinical Benefit Rate (CBR)

    CBR was defined as the percentage of participants who have best overall response (BOR) of complete response (CR), or partial response (PR), or duration of stable disease (dSD) greater than or equal to 11 weeks, between Arm A and Arm B. CBR was estimated by treatment arm based on the tumor response evaluation performed by the PI or designee according to RECIST 1.1. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2011 (estimated)
  2. Study start10 Mar 2011
  3. Primary completion2 Jan 2015
  4. Study completion10 Aug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01327885
Sponsor's protocol ID
E7389-G000-309
Other IDs
2010-024483-17
Status last verified
Feb 2018
First submitted
31 Mar 2011
Last updated
22 Jun 2023
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26874885

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eribulin mesylate 1.4 mg/m^2 intravenous and Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IV in people with Soft Tissue Sarcoma, run by Eisai Inc. at 119 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in United States, France, Brazil, Germany, Italy and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From date of treatment start until date of death from any cause, up to 5 years 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01327885, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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