Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01454934




Trial ID
NCT01454934
Ethics application status
Date submitted
13/10/2011
Date registered
17/10/2011
Date last updated
3/08/2017

Titles & IDs
Public 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
Scientific title
Secondary ID [1] 0 0
E7389-G000-302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer (NSCLC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Eribulin
Treatment: Drugs - TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed

Experimental: Arm A -

Active Comparator: Arm B -


Treatment: Drugs: Eribulin
Administration of eribulin mesylate at a dose of 1.4 mg/m2 i.v. over 2 to 5 minutes on Days 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.

Treatment: Drugs: TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed
Vinorelbine 30 mg/m2 i.v. on Day 1, every 7 days
Gemcitabine 1250 mg/m2 i.v. on Days 1 and 8, every 21 days
Docetaxel 75 mg/m2 i.v. on Day 1 every 21 days
Pemetrexed 500 mg/m2 i.v. on Day 1 every 21 days (nonsquamous histology only).

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - The OS was defined as the time in months from the date of randomization to the date of death, regardless of cause. In the absence of confirmation of death, the 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. The two treatment arms were compared using the log-rank test, stratified by histology, TPC option, and geographic region; and the treatment difference between eribulin and TPC was tested at a significance level of 0.05 (2-sided). Kaplan-Meier (K-M) survival probabilities for each arm were plotted over time. The treatment effect was estimated by fitting a Cox Proportional Hazards model to the OS times including treatment arm as a factor and histology, TPC option and geographic region as strata.
Timepoint [1] 0 0
Randomization (Day 1) until date of death from any cause, or 37 months
Secondary outcome [1] 0 0
Progression Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) - 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 difference in PFS (based on the tumor response evaluation as determined by the investigator) between eribulin and TPC was evaluated using the log rank test, stratified by histology, TPC option, and geographic region, tested at an alpha level of 0.05 (2-sided). PFS censoring rules will be defined in the SAP and follow Federal Department of Agriculture (FDA) guidance.
Timepoint [1] 0 0
Randomization (Day 1) until date of disease progression or death (whichever occurred first), or 37 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR) - The ORR was defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST criteria. The ORR was estimated by study arm based on the tumor response evaluation as determined by the investigator, according to RECIST 1.1. Participants with unknown response were treated as non-responders. The statistical difference in ORR between treatment arms was evaluated using the Cochran-Mantel-Haenszel (CMH) chi-square test with histology, TPC option, and geographic region as strata, tested at an alpha level of 0.05 (2-sided). The 95 percent confidence interval (CI) was calculated using Clopper Pearson method.
Timepoint [2] 0 0
Randomization (Day 1) to CR or PR

Eligibility
Key inclusion criteria
Inclusion:

Subjects must meet all of the following criteria to be included in this study:

1. Histologically or cytologically confirmed diagnosis of NSCLC.

2. Documented evidence of advanced NSCLC not amenable to surgery or radiotherapy.

3. Confirmation of the presence or absence of EGFR mutations prior to study enrolment in
all subjects.

4. Subjects must have received at least two prior regimens for advanced NSCLC, which
should have included a platinum-based regimen and, in all subjects with tumors
harbouring EGFR mutations, an EGFR TKI.

5. Radiographic evidence of disease progression on, or after, the last anti-cancer
regimen prior to study entry.

6. Presence of measurable disease.

7. ECOG performance status of 0, 1, or 2.

8. Adequate bone marrow

9. Adequate renal function.

10. Adequate liver function.

11. Female subjects of child-bearing potential must agree to use two forms of highly
effective contraception.

12. Male subjects and their female partners who are of child-bearing potential must agree
to use two forms of highly effective contraception.

13. Voluntary agreement to provide written informed consent and the willingness and
ability to comply with all aspects of the protocol.

14. Males or females aged at least 18 years (or any age greater than 18 years as
determined by country legislation) at the time of informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion:

Subjects who meet any of the following criteria will be excluded from this study:

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. Peripheral neuropathy more than CTCAE Grade 2.

5. Significant cardiovascular impairment.

6. Subjects with a high probability of Long QT Syndrome, or QTc interval >500 ms.

7. Subjects with brain or subdural metastases are not eligible, unless the metastases are
asymptomatic and do not require treatment or have been adequately treated by local
therapy.

8. Any serious concomitant illness.

9. Known HIV positive, or have an infection requiring treatment.

10. Any malignancy that required treatment, or has shown evidence of recurrence (except
for NSCLC, non-melanoma skin cancer, or histologically confirmed complete excision of
carcinoma in-situ) during the 5 years prior to study entry.

11. Female subjects must not be pregnant, and must not be breastfeeding.

12. Hypersensitivity to either HalB or HalB chemical derivatives or both, or to any of the
excipients of the eribulin formulation.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
QLD,VIC
Recruitment hospital [1] 0 0
- Herston
Recruitment hospital [2] 0 0
- Frankston
Recruitment postcode(s) [1] 0 0
- Herston
Recruitment postcode(s) [2] 0 0
- Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Colorado
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Michigan
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United States of America
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New Hampshire
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United States of America
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New York
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United States of America
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Oregon
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United States of America
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Washington
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United States of America
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Wisconsin
Country [12] 0 0
France
State/province [12] 0 0
Bas Rhin
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France
State/province [13] 0 0
Bouches-du-Rhone
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France
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Bouches-duRhone
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France
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Gironde
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France
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Haute Garonne
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France
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Haute Vienne
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France
State/province [18] 0 0
Ille et Vilaine
Country [19] 0 0
France
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Loire Atlantique
Country [20] 0 0
France
State/province [20] 0 0
Nord
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France
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Paris
Country [22] 0 0
France
State/province [22] 0 0
Rhone
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France
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Val de Marne
Country [24] 0 0
Germany
State/province [24] 0 0
Bayern
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Germany
State/province [25] 0 0
Nordrhein Westfalen
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Germany
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Rheinland Pfalz
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Germany
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Sachsen Anhalt
Country [28] 0 0
Hong Kong
State/province [28] 0 0
Hong Kong
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Italy
State/province [29] 0 0
Lucca
Country [30] 0 0
Italy
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Milano
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Italy
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Pordenone
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Italy
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Cremona
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Italy
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Siena
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Japan
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Aichi-Ken
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Japan
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Chiba-Ken
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Japan
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Fukuoka-Ken
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Japan
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Hiroshima-Ken
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Japan
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Hokkaido
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Japan
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Hygo-Ken
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Japan
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Hyogo-ken
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Japan
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Miyagi-Ken
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Japan
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Nigata-Ken
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Japan
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Okayama-Ken
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Japan
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Osaka-Fu
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Japan
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Shizuoka-Ken
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Japan
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Tokyo-to
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Japan
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Tokyo-To
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Japan
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Yamaguchi-Ken
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Japan
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Kitaadachi-gun
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Korea
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Poland
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Gdansk
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Poland
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Mrozy
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Poland
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Otwock
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Poland
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Sczedin
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Poland
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Warsazawa
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Russian Federation
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Barnaul
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint Petersburg
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Navarra
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Spain
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Madrid
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei City
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Taiwan
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Taipei
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United Kingdom
State/province [68] 0 0
Greater London
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Greater Manchester
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eisai Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety
of eribulin with TPC in subjects with advanced and disease progression following at least two
prior regimens for advanced disease, which should have included a platinum-based regimen.
Trial website
https://clinicaltrials.gov/show/NCT01454934
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries