Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02623751
Recruitment Status : Active, not recruiting
First Posted : December 8, 2015
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin Co., Ltd.

Tracking Information
First Submitted Date  ICMJE November 18, 2015
First Posted Date  ICMJE December 8, 2015
Last Update Posted Date March 12, 2019
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2015)
Number and percentage of subjects with treatment-emergent adverse events including dose-limiting toxicities and serious adverse events [ Time Frame: Assessed up to 28 days after study discontinuation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02623751 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2015)
  • Pharmacokinetics of KHK2375 [maximum concentration (Cmax)] [ Time Frame: 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)] [ Time Frame: 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)] [ Time Frame: Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer
Official Title  ICMJE Phase 1 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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 adminitered 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 adminitered once daily.

    Other Names:
    • Entinostat
    • MS-275
    • SDNX-275
Study Arms  ICMJE Experimental: KHK2375 PO and Exemestane PO
KHK2375 and Exemestane
Interventions:
  • Drug: KHK2375
  • Drug: Exemestane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 3, 2017)
15
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2015)
30
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02623751
Other Study ID Numbers  ICMJE 2375-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyowa Kirin Co., Ltd.
Study Sponsor  ICMJE Kyowa Kirin Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kyowa Kirin Co., Ltd.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP