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  • GSK Breast

    Acronym: 

    GSK Breast

    ACTRN/NCT /ethics: 

    NCT02964507

    Scientific title: 

    A phase I/II dose escalation and expansion study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in combination with fulvestrant in subjects with ER+ breast cancer

    Summary of trial and patient characteristics

    Cancer Type Breast
    Trial Type Treatment
    Phase Phase I, Phase II Tumour Stream Breast
    Age Range 18 years and older Cancer Stage
    Sex Female Anticipated Start Date 2017-02-02
    Molecular Target Anticipated End Date 2022-09-15
    Cancer Type Breast
    Trial Type Treatment
    Phase Phase I, Phase II
    Age Range 18 years and older
    Sex Female
    Molecular Target
    Tumour Stream Breast
    Cancer Stage
    Anticipated Start Date 2017-02-02
    Anticipated End Date 2022-09-15

    Trial Summary

    This is a combination Phase I and Phase II study, with an aim to evaluate the combination of GSK525762 and fulvestrant in women with HR+/HER2- advanced or metastatic breast cancer, who have disease that has progressed after prior treatment with at least one line of endocrine therapy. The objectives of the study are to first identify, in open-label single-arm Phase I, a recommended Phase II dose of GSK525762 that may be combined safely with fulvestrant. Phase I will follow a modified toxicity probability interval (mTPI) design, and a sentinel group will be evaluated first for dose-limiting toxicity and further expanded to collect additional safety data. This will be followed by a double-blind, randomized controlled Phase II, to identify the clinical activity of the two study treatments when given in combination. The composition of Phase II will be selected at the end of Phase I.

    Lay Summary

    A phase I/II dose escalation and expansion study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in combination with fulvestrant in subjects with ER+ breast cancer

    Sponsor / Cooperative group

    GlaxoSmithKline

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Flinders Medical Centre Alex Scott-Hoy alex.scott-hoy@sa.gov.au 08 8204 4830 Professor Bogda Koczwara Recruiting