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
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| ClinicalTrials.gov Identifier: NCT01454934 |
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Recruitment Status :
Completed
First Posted : October 19, 2011
Results First Posted : March 1, 2017
Last Update Posted : June 26, 2019
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Sponsor:
Eisai Inc.
Information provided by (Responsible Party):
Eisai Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-Small Cell Lung Cancer (NSCLC) | Drug: Eribulin Drug: TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 540 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Actual Study Start Date : | December 9, 2011 |
| Actual Primary Completion Date : | May 30, 2014 |
| Actual Study Completion Date : | May 2, 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm A |
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. |
| Active Comparator: Arm B |
Drug: TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed
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Primary Outcome Measures :
- Overall Survival (OS) [ Time Frame: Randomization (Day 1) until date of death from any cause, or 37 months ]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 mesylate 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.
Secondary Outcome Measures :
- Progression Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Randomization (Day 1) until date of disease progression or death (whichever occurred first), or 37 months ]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 mesylate 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.
- Objective Response Rate (ORR) [ Time Frame: Randomization (Day 1) to CR or PR ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454934
Locations
Show 84 study locations
Sponsors and Collaborators
Eisai Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT01454934 |
| Other Study ID Numbers: |
E7389-G000-302 |
| First Posted: | October 19, 2011 Key Record Dates |
| Results First Posted: | March 1, 2017 |
| Last Update Posted: | June 26, 2019 |
| Last Verified: | August 2017 |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Gemcitabine Docetaxel Pemetrexed Vinorelbine Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Antineoplastic Agents, Phytogenic |