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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01454934
First Posted: October 19, 2011
Last Update Posted: September 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc.
  Purpose
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 Intervention Phase
Non-Small Cell Lung Cancer (NSCLC) Drug: Eribulin Drug: TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

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 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 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.


Enrollment: 540
Study Start Date: September 2011
Study Completion Date: May 2, 2016
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • 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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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:

  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.
  Contacts and Locations
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


  Show 84 Study Locations
Sponsors and Collaborators
Eisai Inc.
  More Information

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01454934     History of Changes
Other Study ID Numbers: E7389-G000-302
First Submitted: October 13, 2011
First Posted: October 19, 2011
Results First Submitted: January 11, 2017
Results First Posted: March 1, 2017
Last Update Posted: September 1, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
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
Pemetrexed
Docetaxel
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