Trials / Completed
CompletedNCT02623751
Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer
Phase 1 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Kyowa Kirin Co., Ltd. · Industry
- Sex
- Female
- Age
- 20 Years – 74 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KHK2375 | 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. |
| DRUG | Exemestane | 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. |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2020-10-01
- Completion
- 2020-10-01
- First posted
- 2015-12-08
- Last updated
- 2022-06-21
Locations
3 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02623751. Inclusion in this directory is not an endorsement.