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Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

Sponsor
Kyowa Kirin Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02623751
Collaborator
(none)
15
Enrollment
3
Locations
1
Arm
59
Actual Duration (Months)
5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 1 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer
Actual Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Oct 1, 2020
Actual Study Completion Date :
Oct 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: KHK2375 PO and Exemestane PO

KHK2375 and Exemestane

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.
Other Names:
  • Entinostat
  • MS-275
  • SDNX-275

    		•

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. 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]

    2. 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]

    3. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 74 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chikusa-ku Aichi Japan
    2 Chuo-ku Osaka Japan
    3 Chuo-ku Tokyo Japan

    Sponsors and Collaborators

    • Kyowa Kirin Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kyowa Kirin Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02623751
    Other Study ID Numbers:
    • 2375-001
    First Posted:
    Dec 8, 2015
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Additional relevant MeSH terms:
    Breast Neoplasms
    Exemestane
    Entinostat

    Study Results

    No Results Posted as of Jun 21, 2022