The primary objective of the open-label, dose-escalation study is to investigate the safety of single-dose monotherapy and repeated-dose of KHK2375 combined with exemestane in female subjects with advanced or recurrent breast cancer. The secondary objective is to investigate the pharmacokinetics and efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
KHK2375 will be orally administered once weekly. KHK2375 in combination with exemestane will be repeatedly administered in a 28-day cycle. Exemestane will be orally administered once daily.
KHK2375 will be orally administered once weekly. KHK2375 in combination with exemestane will be repeatedly administered in a 28-day cycle. Exemestane will be orally administered once daily.
Unnamed facility
Chikusa-ku, Aichi-ken, Japan
Unnamed facility
Chuo-ku, Osaka, Japan
Unnamed facility
Chuo-ku, Tokyo, Japan
Number and percentage of subjects with treatment-emergent adverse events including dose-limiting toxicities and serious adverse events
Time frame: Assessed up to 28 days after study discontinuation
Pharmacokinetics of KHK2375 [maximum concentration (Cmax)]
Time frame: Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1
Pharmacokinetics of KHK2375 [Area under the curve (AUC)]
Time frame: Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1
Pharmacokinetics of KHK2375 [Half-life (t1/2)]
Time frame: Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1
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