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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01454934
First received: October 13, 2011
Last updated: July 22, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Evaluation of Overall Survival [ Time Frame: From randomization until 37 months ] [ Designated as safety issue: No ]
    OS, measured from the date of randomization until date of death from any cause. In absence of confirmation of death, subjects will be censored either at the date that the subject was last known to be alive or the date of study cut-off, whichever comes earlier


Secondary Outcome Measures:
  • Evaluation of Progression Free Survival by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: From randomization until 37 months ] [ Designated as safety issue: No ]
    PFS, defined as the time from the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurs first. PFS censoring rules will be defined in the SAP and follow FDA guidance.


Estimated Enrollment: 540
Study Start Date: September 2011
Estimated Study Completion Date: July 2014
Primary Completion Date: April 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454934

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

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01454934     History of Changes
Other Study ID Numbers: E7389-G000-302
Study First Received: October 13, 2011
Last Updated: July 22, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Docetaxel
Gemcitabine
Pemetrexed
Vinorelbine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 30, 2014