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Trial registered on ANZCTR


Registration number
ACTRN12612000100897
Ethics application status
Approved
Date submitted
19/01/2012
Date registered
20/01/2012
Date last updated
9/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Treatment of Physician's Choice in Subjects With Advanced Non-Small Cell Lung Cancer
Scientific title
A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin with Treatment of Physician’s Choice in Subjects with Advanced Non-Small Cell Lung Cancer.
Secondary ID [1] 279758 0
ClinicalTrials.gov Identifier: NCT01454934
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small cell lung cancer 285607 0
Condition category
Condition code
Cancer 285802 285802 0 0
Lung - Non small cell

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] 284061 0
Treatment: Drugs
Comparator / control treatment
Treatment of Physician's choice:
1. Vinorelbine or
2. Gemcitabine or
3. Docetaxel or
4. Pemetrexed (nonsquamous histology only).
TPC option doses and schedules as per local/regional prescribing information
Control group
Active

Outcomes
Primary outcome [1] 286312 0
Overall survival measured from the date of randomisation until date of death from any cause.
Timepoint [1] 286312 0
This will be performed when the target number of events
(~425 deaths) has been observed; this is estimated to take approximately 31 months from the start of the Randomization Phase assuming an accrual rate of 20 subjects per month.
Secondary outcome [1] 295591 0
To compare progression-free survival (PFS) between Arm A and Arm B.
Timepoint [1] 295591 0
Patients will be followed up 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 or Cytologically confirmed diagnosis of NSCLC
2. Advanced NSCLC not amenable to surgery or radiotherapy, with radiological evidence of disease progression following the last anti-cancer treatment.
3. Presence of Measurable Tumour Disease
4. Confirmation of the presence or absence of EGFR mutations prior to study enrolment. However, subjects with unknown EGFR status and who have received prior treatment with an EGFR Tyrosine Kinase Inhibitor (TKI) can be enrolled.
5. Subjects must have received at least two prior regimens of treatment for advanced NSCLC, which should have included a platinum based treatment and in subjects with tumours harbouring EGFR mutations, an EGFR TKI.
6. ECOG performance status 0,1 or 2
7. Adequate Liver, Renal and Bone marrow functions.
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 within 14 days, or five half-lives of the drug (whichever is longer), prior to randomization
2. Subjects who have not recovered from toxicities as a result of prior anti-cancer therapy to less than Grade 2
3. Subjects who have previously been treated, or participated in a study with eribulin, whether treated with eribulin or not. The TPC option must not include the same agent which the subject received in a prior regimen
4. Pre-existing peripheral neuropathy more than CTCAE
Grade 2
5. Significant cardiovascular impairment
6. Subjects with a high probability of Long QT Syndrome
7. Subjects with active brain or subdural 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)
Randomization will be in a 1:1 ratio (eribulin : TPC) and stratified by histology (squamous cell or non-squamous cell carcinoma), TPC option as determined prior to randomization for all subjects (vinorelbine, or gemcitabine, or docetaxel, or pemetrexed), and geographic region (region 1: USA and Canada, Western Europe and Australia, or region 2: Eastern Europe and Asia [excluding Japan], or region 3: Japan).
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
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,QLD,SA
Recruitment outside Australia
Country [1] 4057 0
United States of America
State/province [1] 4057 0
Country [2] 4058 0
United Kingdom
State/province [2] 4058 0
Country [3] 4059 0
France
State/province [3] 4059 0
Country [4] 4060 0
Germany
State/province [4] 4060 0
Country [5] 4061 0
Italy
State/province [5] 4061 0
Country [6] 4062 0
Spain
State/province [6] 4062 0
Country [7] 4063 0
Poland
State/province [7] 4063 0
Country [8] 4064 0
Russian Federation
State/province [8] 4064 0
Country [9] 4065 0
Singapore
State/province [9] 4065 0
Country [10] 4066 0
Korea, Republic Of
State/province [10] 4066 0
Country [11] 4067 0
Hong Kong
State/province [11] 4067 0
Country [12] 4068 0
Taiwan, Province Of China
State/province [12] 4068 0
Country [13] 5399 0
Japan
State/province [13] 5399 0

Funding & Sponsors
Funding source category [1] 284531 0
Commercial sector/Industry
Name [1] 284531 0
Eisai Limited
Address [1] 284531 0
Mosquito Way
Hatfield, Hertfordshire
AL10 9SN
Country [1] 284531 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] 283460 0
Commercial sector/Industry
Name [1] 283460 0
Eisai Inc
Address [1] 283460 0
300 Tice Boulevard
Woodcliff Lake,
New Jersey 07677
Country [1] 283460 0
United States of America
Other collaborator category [1] 260459 0
Commercial sector/Industry
Name [1] 260459 0
Quintiles Pty Ltd
Address [1] 260459 0
Level 8, 67 Albert Avenue
Chatswood, New South Wales, 2067
Country [1] 260459 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286517 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 286517 0
229 Greenhill Road
Dulwich SA 5065
Ethics committee country [1] 286517 0
Australia
Date submitted for ethics approval [1] 286517 0
Approval date [1] 286517 0
14/11/2011
Ethics approval number [1] 286517 0
2011-08-415
Ethics committee name [2] 286534 0
Copernicus Group IRB
Ethics committee address [2] 286534 0
One Triangle Drive Suite 100
Durham NC 27713
Ethics committee country [2] 286534 0
United States of America
Date submitted for ethics approval [2] 286534 0
Approval date [2] 286534 0
21/07/2011
Ethics approval number [2] 286534 0

Summary
Brief summary
This is a randomized, open-label, multicenter, Phase 3 study, comparing the efficacy and safety of eribulin with TPC in subjects with advanced NSCLC and disease progression following at least two prior regimens for advanced disease, which should have included a platinum-based regimen.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33647 0
Dr Vinod Ganju
Address 33647 0
Peninsula Oncology Centre
24-28 Frankston Flinders Rd
Frankston
Victoria 3199
Country 33647 0
Australia
Phone 33647 0
+61 3 9771 8900
Fax 33647 0
Email 33647 0
vg@poc.com.au
Contact person for public queries
Name 16894 0
Ms Xui-Ming Lee
Address 16894 0
152 Beach Road #15-05/08
Gateway East
Country 16894 0
Singapore
Phone 16894 0
+65 6297 6624
Fax 16894 0
Email 16894 0
x-lee@ecs.eisai.com.sg
Contact person for scientific queries
Name 7822 0
Dr Martin Olivo
Address 7822 0
Eisai Inc.
300 Tice Boulevard
Woodcliff Lake
New Jersey 07677
Country 7822 0
United States of America
Phone 7822 0
+1 201 949 4000
Fax 7822 0
Email 7822 0
Martin_Olivo@eisai.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary