Trial from ANZCTR


Trial ID ACTRN12611001074987
Trial Status: Registered
Date Submitted: 14/10/2011
Date Registered: 17/10/2011
Retrospectively registered

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Public title Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma
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Secondary ID [1] 273167 0
ClinicalTrials.gov Identifier: NCT01327885
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Soft tissue sarcoma 278917 0
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Condition category: Condition code:
Cancer Sarcoma (also see 'Bone') - soft tissue
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279096 279096 0 0

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Descriptions of intervention(s) / exposure Administration of eribulin mesylate at a dose of 1.4 mg/m2 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. Treatment will continue until disease progression, development of unacceptable toxicity or withdrawal of consent.
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Intervention Code:
Treatment: drugs 269497 0
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Comparator / control treatment Administration of dacarbazine at a dose of 850 mg/m2, or 1,000 mg/m2, or 1,200 mg/m2 selected by the PI or designee prior to randomization according to the subject’s clinical status as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every cycle, where the duration of each cycle is 21 days. Treatment will continue until disease progression, development of unacceptable toxicity or withdrawal of consent.
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Control group Active
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Primary Outcome: Overall survival measured from the date of randomisation until date of death from any cause. 279734 0
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Timepoint: When the target number of events (~353 deaths) has been observed; this is estimated to take approximately 29 months from the start of the study assuming an accrual rate of 20 subjects per month. 279734 0
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Secondary Outcome: To compare progression-free survival (PFS) between Arm A and Arm B. 294327 0
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Timepoint: Time from the date of randomization to the date of first documentation of disease progression, or date of death (whichever occurs first). 294327 0
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Key inclusion criteria 1. Histologically confirmed diagnosis of soft tissue sarcoma of high or intermediate grade with one of the following histological subtypes: a. Adipocytic sarcoma b. Leiomyosarcoma. 2. Documented evidence of advanced adipocytic or leiomyosarcoma, incurable by surgery and/or radiotherapy. 3. Subjects should have received at least two standard systemic regimens for advanced soft tissue sarcoma one of which must have included an anthracycline (unless contraindicated). 4. Radiographic evidence of disease progression within the 6 months prior to randomization. 5. Presence of measurable disease. 6. Eastern Cooperative Oncology Group, performance status of 0, 1 or 2. 7. Adequate renal function. 8. Adequate bone marrow function. 9. Adequate liver function.
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Minimum age 18 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria 1. Subjects who have received any anti-cancer therapy, including surgery or intratumoral therapy, radiotherapy, chemotherapy, hormonal, biological, immunotherapy and targeted agents within 21 days, or five half-lives of the drug (whichever is longer), prior to randomization. 2. Subjects who have not recovered from acute toxicities as a result of prior anti-cancer therapy to =/< Grade 1. 3. Subjects that have previously been treated with dacarbazine or participated in a study with eribulin. 4. Pre-existing peripheral neuropathy > CTCAE Grade 2. 5. Significant cardiovascular impairment. 6. Subjects with a high probability of Long QT Syndrome. 7. Subjects with known central nervous system metastases.
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Allocation of randomization numbers will be performed using an interactive voice/web response system vendor
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) The randomisation list was created prospectively using a bespoke computer program to create permuted blocks of a pre-defined size to ensure balance of subjects between the 2 treatment groups in a ratio of 1:1. The randomisation was stratified according to region, histology sub-type, and number of prior chemotherapy regimens, with separate lists being created for each strata combination.
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Phase 3
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Anticipated date of first participant enrolment 22/03/2011
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled 28/05/2013
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Target sample size 450
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Recruitment status Active, not recruiting
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Recruitment in Australia

Recruitment state(s) NSW,QLD,SA,WA
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Postcode: 4102 4572 0
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Postcode: 5011 4573 0
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Postcode: 6009 4574 0
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Postcode: 2050 4575 0
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Recruitment outside Australia

Country: United States of America 3880 0
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State/Province: 3880 0
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Country: Austria 3881 0
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State/Province: 3881 0
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Country: Belgium 3882 0
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State/Province: 3882 0
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Country: Brazil 3883 0
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State/Province: 3883 0
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Country: Czech Republic 3884 0
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State/Province: 3884 0
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Country: Canada 3885 0
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State/Province: 3885 0
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Country: Denmark 3886 0
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State/Province: 3886 0
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Country: France 3887 0
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State/Province: 3887 0
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Country: Germany 3888 0
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State/Province: 3888 0
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Country: Israel 3889 0
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State/Province: 3889 0
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Country: Italy 3890 0
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State/Province: 3890 0
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Country: Korea, Republic Of 3891 0
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State/Province: 3891 0
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Country: New Zealand 3892 0
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State/Province: 3892 0
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Country: Netherlands 3893 0
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State/Province: 3893 0
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Country: Poland 3894 0
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State/Province: 3894 0
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Country: Romania 3895 0
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State/Province: 3895 0
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Country: Russian Federation 3896 0
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State/Province: 3896 0
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Country: Singapore 3897 0
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State/Province: 3897 0
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Country: Spain 3898 0
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State/Province: 3898 0
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Country: Thailand 3899 0
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State/Province: 3899 0
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Country: United Kingdom 3900 0
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State/Province: 3900 0
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Country: Argentina 4908 0
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State/Province: 4908 0
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Funding Source: Commercial sector/Industry 269978 0
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Name: Eisai Limited 269978 0
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Address: Mosquito Way
Hatfield, Hertfordshire
AL10 9SN
269978 0
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Country: United Kingdom 269978 0
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Primary Sponsor Commercial sector/Industry
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Name: Eisai Limited
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Address: Mosquito Way
Hatfield, Hertfordshire
AL10 9SN
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Country: United Kingdom
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Secondary Sponsor: Commercial sector/Industry 268970 0
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Name: Eisai Inc 268970 0
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Address: 300 Tice Boulevard
Woodcliff Lake,
New Jersey 07677
268970 0
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Country: United States of America 268970 0
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Other Collaborator: Commercial sector/Industry 252281 0
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Name: PPD Australia Pty Ltd 252281 0
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Address: Level 9
5 Queens Road
Melbourne VIC 3004
252281 0
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Country: Australia 252281 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: HUMAN RESEARCH ETHICS COMMITTEE (TQEH/LMH/MH) 271941 0
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Address: The Queen Elizabeth Hospital
Lyell McEwin Hospital
Modbury Hospital
Ph: +61 08 8222 6841
Fax: +61 08 8222 6007
Email: qeh.ethics@health.sa.gov.au
271941 0
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Country: Australia 271941 0
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Approval Date: 05/08/2011 271941 0
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Submitted Date: 14/04/2011 271941 0
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HREC: 2011050 271941 0
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Ethics Committee name: Metro South Health Service District HREC 271942 0
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Address: Building 15 Level 3
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba Qld 4120
General Phone: +61 7 3240 7744
General Fax: +61 7 3240 7262
email: PAH_Ethics_Research@health.qld.gov.au
271942 0
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Country: Australia 271942 0
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Approval Date: 25/08/2011 271942 0
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Submitted Date: 14/04/2011 271942 0
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HREC: HREC/11/QPAH/248 271942 0
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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 at least 2 standard systemic regimens for advanced soft tissue sarcoma one of which must have included an anthracycline, unless contraindicated.
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Trial website
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Public Notes
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Principal Investigator
Title: Dr
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Name: Warren Joubert
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Address: Princess Alexandra Hospital Ipswich Road Cancer Services Level 2, Building 1 Woolloongabba Qld 4102
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Country: Australia
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Tel: +61 7 3240 2111
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Email: warren_joubert@health.qld.gov.au
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Contact person for public queries
Title: Ms
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Name: Xui Ming Lee
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Address: 152 Beach Road #15-05/08 Gateway East
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Country: Singapore
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Tel: +65 6297 6624
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Email: x-lee@ecs.eisai.com.sg
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Contact person for scientific queries
Title: Dr
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Name: Carlos Chanquia
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Address: Mosquito Way Hatfield, Hertfordshire AL10 9SN
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Country: United Kingdom
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Tel: Eisai Medical Services 1-888-422-4743
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Email: carlos_chanquia@eisai.net
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Contact person responsible for updating information
Title:
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Name: Xui Ming Lee
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Address: 152 Beach Road #15-05/08 Gateway East
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Country: Singapore
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Tel: +65 6297 6624
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Email: x-lee@ecs.eisai.com.sg
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Addition Cancer fields
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