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  • XL184-401

    Acronym: 

    XL184-401

    ACTRN/NCT /ethics: 

    NCT01896479

    Scientific title: 

    A Randomized, Double-blind Study To Evaluate the Efficacy and Safety of Cabozantinib (XL184) at 60 mg/Day Compared to a 140 mg/Day in Progressive, Metastatic Medullary Thyroid Cancer Patients

    Summary of trial and patient characteristics

    Cancer Type Thyroid
    Trial Type Treatment
    Phase All phases Tumour Stream Medullary Thyroid
    Age Range 18 years and older Cancer Stage Locally Recurrent or Locally Advanced, Metastatic or Widespread
    Sex Both Anticipated Start Date 2014-12-01
    Molecular Target Anticipated End Date 2018-03-01
    Cancer Type Thyroid
    Trial Type Treatment
    Phase All phases
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Medullary Thyroid
    Cancer Stage Locally Recurrent or Locally Advanced, Metastatic or Widespread
    Anticipated Start Date 2014-12-01
    Anticipated End Date 2018-03-01

    Trial Summary

    The objective of this study is to evaluate the efficacy and safety of oral cabozantinib at a 60 mg dose compared with a 140 mg dose in subjects with progressive, metastatic MTC. It will test if the lower dose results in similar progression free survival (PFS) and overall response rate (ORR) with fewer adverse events compared to the PFS, ORR and adverse events found in previous clinical trials of 140 mg.

    Lay Summary

    A Randomized, Double-blind Study To Evaluate the Efficacy and Safety of Cabozantinib (XL184) at 60 mg/Day Compared to a 140 mg/Day in Progressive, Metastatic Medullary Thyroid Cancer Patients

    Sponsor / Cooperative group

    Exelixis

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Ashford Cancer Centre Research Helen Daykin hdaykin@adelaidecancercentre.com.au 08 8292 2240 Recruiting