Trial registered on ANZCTR


Trial ID
ACTRN12611001074987
Ethics application status
Approved
Date submitted
14/10/2011
Date registered
17/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma
Scientific 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
Secondary ID [1] 273167 0
ClinicalTrials.gov Identifier: NCT01327885
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soft tissue sarcoma 278917 0
Condition category
Condition code
Cancer 279096 279096 0 0
Sarcoma (also see 'Bone') - soft tissue

Intervention/exposure
Study type
Interventional
Description 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.
Intervention code [1] 269497 0
Treatment: drugs
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.
Control group
Active

Outcomes
Primary outcome [1] 279734 0
Overall survival measured from the date of randomisation until date of death from any cause.
Timepoint [1] 279734 0
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.
Secondary outcome [1] 294327 0
To compare progression-free survival (PFS) between Arm A and Arm B.
Timepoint [1] 294327 0
Time from the date of randomization to the date of first documentation of disease progression, or date of death (whichever occurs first).

Eligibility
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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy

Recruitment
Anticipated date of first participant enrolment
22/03/2011
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
28/05/2013
Anticipated date of last data collection
Actual date of last data collection
Target sample size
450
Actual sample size
Recruitment status
Active, not recruiting
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment postcode(s) [1] 4572 0
4102
Recruitment postcode(s) [2] 4573 0
5011
Recruitment postcode(s) [3] 4574 0
6009
Recruitment postcode(s) [4] 4575 0
2050
Recruitment outside Australia
Country [1] 3880 0
United States of America
State/province [1] 3880 0
Country [2] 3881 0
Austria
State/province [2] 3881 0
Country [3] 3882 0
Belgium
State/province [3] 3882 0
Country [4] 3883 0
Brazil
State/province [4] 3883 0
Country [5] 3884 0
Czech Republic
State/province [5] 3884 0
Country [6] 3885 0
Canada
State/province [6] 3885 0
Country [7] 3886 0
Denmark
State/province [7] 3886 0
Country [8] 3887 0
France
State/province [8] 3887 0
Country [9] 3888 0
Germany
State/province [9] 3888 0
Country [10] 3889 0
Israel
State/province [10] 3889 0
Country [11] 3890 0
Italy
State/province [11] 3890 0
Country [12] 3891 0
Korea, Republic Of
State/province [12] 3891 0
Country [13] 3892 0
New Zealand
State/province [13] 3892 0
Country [14] 3893 0
Netherlands
State/province [14] 3893 0
Country [15] 3894 0
Poland
State/province [15] 3894 0
Country [16] 3895 0
Romania
State/province [16] 3895 0
Country [17] 3896 0
Russian Federation
State/province [17] 3896 0
Country [18] 3897 0
Singapore
State/province [18] 3897 0
Country [19] 3898 0
Spain
State/province [19] 3898 0
Country [20] 3899 0
Thailand
State/province [20] 3899 0
Country [21] 3900 0
United Kingdom
State/province [21] 3900 0
Country [22] 4908 0
Argentina
State/province [22] 4908 0

Funding & Sponsors
Funding source category [1] 269978 0
Commercial sector/Industry
Name [1] 269978 0
Eisai Limited
Address [1] 269978 0
Mosquito Way
Hatfield, Hertfordshire
AL10 9SN
Country [1] 269978 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Eisai Limited
Address
Mosquito Way
Hatfield, Hertfordshire
AL10 9SN
Country
United Kingdom
Secondary sponsor category [1] 268970 0
Commercial sector/Industry
Name [1] 268970 0
Eisai Inc
Address [1] 268970 0
300 Tice Boulevard
Woodcliff Lake,
New Jersey 07677
Country [1] 268970 0
United States of America
Other collaborator category [1] 252281 0
Commercial sector/Industry
Name [1] 252281 0
PPD Australia Pty Ltd
Address [1] 252281 0
Level 9
5 Queens Road
Melbourne VIC 3004
Country [1] 252281 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271941 0
HUMAN RESEARCH ETHICS COMMITTEE (TQEH/LMH/MH)
Ethics committee address [1] 271941 0
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
Ethics committee country [1] 271941 0
Australia
Date submitted for ethics approval [1] 271941 0
14/04/2011
Approval date [1] 271941 0
05/08/2011
Ethics approval number [1] 271941 0
2011050
Ethics committee name [2] 271942 0
Metro South Health Service District HREC
Ethics committee address [2] 271942 0
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
Ethics committee country [2] 271942 0
Australia
Date submitted for ethics approval [2] 271942 0
14/04/2011
Approval date [2] 271942 0
25/08/2011
Ethics approval number [2] 271942 0
HREC/11/QPAH/248

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33236 0
Dr Warren Joubert
Address 33236 0
Princess Alexandra Hospital
Ipswich Road
Cancer Services
Level 2, Building 1
Woolloongabba
Qld 4102
Country 33236 0
Australia
Phone 33236 0
+61 7 3240 2111
Fax 33236 0
Email 33236 0
warren_joubert@health.qld.gov.au
Contact person for public queries
Name 16483 0
Ms Xui Ming Lee
Address 16483 0
152 Beach Road #15-05/08
Gateway East
Country 16483 0
Singapore
Phone 16483 0
+65 6297 6624
Fax 16483 0
Email 16483 0
x-lee@ecs.eisai.com.sg
Contact person for scientific queries
Name 7411 0
Dr Carlos Chanquia
Address 7411 0
Mosquito Way
Hatfield, Hertfordshire
AL10 9SN
Country 7411 0
United Kingdom
Phone 7411 0
Eisai Medical Services 1-888-422-4743
Fax 7411 0
Email 7411 0
carlos_chanquia@eisai.net