Status:
COMPLETED
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
Lead Sponsor:
Eisai Inc.
Conditions:
Non-Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Inclusion:
- Subjects must meet all of the following criteria to be included in this study:
- Histologically or cytologically confirmed diagnosis of NSCLC.
- Documented evidence of advanced NSCLC not amenable to surgery or radiotherapy.
- Confirmation of the presence or absence of EGFR mutations prior to study enrolment in all subjects.
- 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.
- Radiographic evidence of disease progression on, or after, the last anti-cancer regimen prior to study entry.
- Presence of measurable disease.
- ECOG performance status of 0, 1, or 2.
- Adequate bone marrow
- Adequate renal function.
- Adequate liver function.
- Female subjects of child-bearing potential must agree to use two forms of highly effective contraception.
- Male subjects and their female partners who are of child-bearing potential must agree to use two forms of highly effective contraception.
- Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
- 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:
- Subjects who have received any anti-cancer therapy within 14 days, or five half-lives of the drug (whichever is longer), prior to randomization.
- Subjects who have not recovered from toxicities as a result of prior anti-cancer therapy to less than Grade 2.
- 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.
- Peripheral neuropathy more than CTCAE Grade 2.
- Significant cardiovascular impairment.
- Subjects with a high probability of Long QT Syndrome, or QTc interval \>500 ms.
- 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.
- Any serious concomitant illness.
- Known HIV positive, or have an infection requiring treatment.
- 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.
- Female subjects must not be pregnant, and must not be breastfeeding.
- Hypersensitivity to either HalB or HalB chemical derivatives or both, or to any of the excipients of the eribulin formulation.
Exclusion
Key Trial Info
Start Date :
December 9 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2016
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT01454934
Start Date
December 9 2011
End Date
May 2 2016
Last Update
June 22 2023
Active Locations (83)
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Los Angeles, California, United States
2
Pleasant Hill, California, United States
3
San Diego, California, United States
4
Aurora, Colorado, United States