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Clinical trial

Everolimus as First-Line Therapy in Treating Patients With Prostate Cancer

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Last updated:1st Sep 2009
Source: Clinical Trials
Identifier: NCT00976755

Rationale:
Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Purpose:
This phase II trial is studying the side effects of everolimus and to see how well it works as first-line therapy in treating patients with prostate cancer.

Primary Outcome Measures:

  • Progression-free survival [ Time Frame: at 12 weeks ]

 

Secondary Outcome Measures:

  • Progression-free survival [ Time Frame: at 24 weeks ]
  • Progression-free survival [ Time Frame: from start of treatment until progression or death of any cause ]
  • from start of treatment until progression or death of any cause, whereas it will be censored at the last follow-up visit or initiation of a different treatment.

 

  • Adverse events according to NCI CTCAE v. 3.0 [ Time Frame: from start of treatment until progression or death of any cause ]
  • PSA response [ Time Frame: 50% and 30%, best and at 12 weeks ]
  • Changes in PSA-doubling time [ Time Frame: Time points for later calculations include: after 12 weeks, after 24 weeks and at best PSA response ]
  • Tumor assessment of measurable disease according to RECIST v1.1 criteria [ Time Frame: The first assessment will be performed after 12 weeks of treatment, or earlier if clinically indicated. ]
  • Tumor assessment of bone lesions [ Time Frame: at 12 weeks. ]
Category Value
Date last updated at source 2016-04-14
Study type(s) Interventional
Expected enrolment 37
Study start date 2009-09-01
Estimated primary completion date 2010-08-01

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