Clinical trial · Interventional
Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer
Phase 1 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer
NCT02623751CI-TRIAL-00059199completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exemestane | Drug | Exemestane | ALIAS |
| KHK2375 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- KHK2375 PO and Exemestane PO
- description
- KHK2375 and Exemestane
- interventionNames
- Drug: KHK2375
- Drug: Exemestane
Primary outcomes (1)
- measure
- Number and percentage of subjects with treatment-emergent adverse events including dose-limiting toxicities and serious adverse events
- timeFrame
- Assessed up to 28 days after study discontinuation
Secondary outcomes (3)
- measure
- Pharmacokinetics of KHK2375 [maximum concentration (Cmax)]
- timeFrame
- Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMasuda N, Tamura K, Yasojima H, Shimomura A, Sawaki M, Lee MJ, Yuno A, Trepel J, Kimura R, Nishimura Y, Saji S, Iwata H. Phase 1 trial of entinostat as monotherapy and combined with exemestane in Japanese patients with hormone receptor-positive advanced breast cancer. BMC Cancer. 2021 Nov 24;21(1):1269. doi: 10.1186/s12885-021-08973-4. PMID 34819039