NCT02623751

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 breast-cancer

Timeline
Completed

Started Nov 2015

Typical duration for phase_1 breast-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

4.9 years

First QC Date

November 18, 2015

Last Update Submit

June 15, 2022

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (1)

KHK2375 PO and Exemestane PO

EXPERIMENTAL

KHK2375 and Exemestane

Drug: KHK2375Drug: Exemestane

Interventions

KHK2375DRUG

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.

KHK2375 PO and Exemestane PO
ExemestaneDRUG

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.

Also known as: Entinostat, MS-275, SDNX-275
KHK2375 PO and Exemestane PO

Eligibility Criteria

Age20 Years - 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Chikusa-ku, Aichi-ken, Japan

Location

Unknown Facility

Chuo-ku, Osaka, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, Japan

Location

Related Publications (1)

  • Masuda 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: 34819039DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestaneentinostat

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2015

First Posted

December 8, 2015

Study Start

November 1, 2015

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

June 21, 2022

Record last verified: 2022-06

Locations

JP(3)