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 | Not Recruiting
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
Health Conditions
  • Non-Small Cell Lung Cancer (NSCLC)
Not Recruiting
Recruitment Status
NCT01454934
Primary Trial ID Number
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.
Primary Outcome Measures
  • Evaluation of Overall Survival; From randomization until 37 months
Secondary Outcome Measures
  • Evaluation of Progression Free Survival by Response Evaluation Criteria in Solid Tumors (RECIST); From randomization until 37 months
Research Question
  • 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.
Design Type
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Ethics Approval
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Publications
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Countries of Recruitment
United States; Australia; France; Germany; Hong Kong; Italy; Japan; Korea, Republic of; Poland; Russian Federation; Singapore; Spain; Taiwan; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
540
Participant 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.
  • 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.
Participant Exclusion 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.
  • 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.
Interventions
Drug; 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.; [Arm A]; Drug; 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).; [Arm B]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific Title
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Secondary Trial Identifying Number
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Website
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Study Funded By
Eisai Inc.
Funder Type
Sorry, this information is not available
Study Sponsored By
Eisai Inc.
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

13 Oct 2011

Last Updated

22 Jul 2014

Date Record Refreshed on UKCTG

31 Jul 2015