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Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

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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.

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
Breast Cancer Drug: KHK2375 Drug: Exemestane Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
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
Study Start Date : November 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Exemestane

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 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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623751


Locations
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Japan
Chikusa-ku, Aichi, Japan
Chuo-ku, Osaka, Japan
Chuo-ku, Tokyo, Japan
Sponsors and Collaborators
Kyowa Kirin Co., Ltd.

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Responsible Party: Kyowa Kirin Co., Ltd.
ClinicalTrials.gov Identifier: NCT02623751     History of Changes
Other Study ID Numbers: 2375-001
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs