Breast Cancer
Conditions
Brief summary
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.
Interventions
DRUGKHK2375
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.
DRUGExemestane
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.
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Postmenopausal women aged ≥ 20 and \< 75 years at the time of consent; * Estrogen receptor positive and/or progesterone receptors positive; * HER2-negative * Nonresectable advanced or recurrent breast cancer previously treated with nonsteroidal aromatase inhibitor (AI), and planning to be treated with exemestane
Exclusion criteria
* Radiation therapy or immuno therapy within 14 days before the first dose of investigational product; * Chemotherapy, biological medicines, other pharmacotherapy or major surgery within 21 days before the first dose of the investigational product; * Prior chemotherapies of ≥ 3 regimens for advanced or recurrent breast cancer; * Ongoing treatment with other investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and percentage of subjects with treatment-emergent adverse events including dose-limiting toxicities and serious adverse events | Assessed up to 28 days after study discontinuation |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of KHK2375 [maximum concentration (Cmax)] | 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)] | 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)] | Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1 |
Countries
Japan
Outcome results
None listed