This trial will assess the intratumoural pharmacological activity of BN83495 by changes in intratumoural levels of sex hormones and associated inhibition of steroid sulphatase (STS) activity.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
2
40mg tablet oral daily administration from Day 1 to Day 14.
Akershus University Hospital
Lørenskog, Norway
Intratumoural levels of sex hormones
Time frame: Baseline and Day 14
Intratumoural steroid sulphatase activity
Time frame: Baseline and Day 14
Change in the intratumoural Ki67 proliferation index
Time frame: Baseline and Day 14
Proportion of subjects with a decrease in Ki67 staining ≥50%
Time frame: Baseline and Day 14
Proportion of subjects with complete cell cycle response, defined as Ki67 staining ≤1%
Time frame: Baseline and Day 14
Change in Apoptotic Index determined by M30 antibody
Time frame: Baseline and Day 14
Change in Growth Index (Ki67 proliferation index/M30 apoptotic index)
Time frame: Baseline and Day 14
Change in steroid sulphatase activity in peripheral blood mononuclear cells (PBMCs).
Time frame: Baseline and Day 14
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