A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficac... | Completed
A Randomized, Open-label, Multicent... | 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

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Medical Conditions
  • Non-Small Cell Lung Cancer (NSCLC)
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT01454934

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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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Eribulin, Drug : TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed

Study Arm Groups : Arm A, Arm B

Intervention Type
See Interventions above
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
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
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
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
London
Greater London
Manchester
Sutton
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Singapore, Spain, Taiwan, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Sorry, this information is not available
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
E7389-G000-302
Sponsor(s)
Eisai Inc.
Key Dates

Recruitment Start Date

Sep 2011

Recruitment End Date

Jul 2015

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

13 Oct 2011

Date updated in source

22 Jun 2016