Phase 1 study of KHK2375 in subjects with advanced or recurrent breast cancer
- Conditions
- Advanced or recurrent breast cancer
- Registration Number
- JPRN-jRCT2080223012
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
In the DLT evaluation of KHK2375 in patients with progressed / relapse Japanese breast cancer, tolerabilitythe was confirmed in dose range was 3 to 10 mg for a single oral administration, and 5 mg for daily oral administration in combination with exemestane 25 mg. Tolerability was also confirmed in continuous oral administration of exemestane 25 mg daily and in combination after the end of the DLT observation period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Female
- Target Recruitment
- 12
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Safety
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacokinetics<br>Pharmacokinetics and efficacy