Trials / Completed
CompletedNCT03291886
Phase 2 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer
Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 133 (actual)
- Sponsor
- Kyowa Kirin Co., Ltd. · Industry
- Sex
- Female
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to investigate the effect of 5 mg KHK2375 on progression free survival (PFS) when administered orally at weekly intervals in combination with exemestane in a placebo-controlled, double-blind comparative study in subjects with advanced or recurrent hormone receptor-positive breast cancer. The secondary objectives are to investigate the effect of on overall survival (OS) and the antitumor effect and to evaluate the pharmacokinetics and safety.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Entinostat | Given PO |
| DRUG | Entinostat(Placebo) | Given PO |
| DRUG | Exemestane | Given PO |
Timeline
- Start date
- 2017-09-22
- Primary completion
- 2019-04-04
- Completion
- 2021-03-26
- First posted
- 2017-09-25
- Last updated
- 2022-06-21
Locations
28 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03291886. Inclusion in this directory is not an endorsement.