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Completed

NCT Number: NCT02623751

Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Chikusa-ku, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KHK2375

Drug

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.

Exemestane

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

Phase 1 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Dec 8, 2015
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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