Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02623751
• Other study ID #: 2375-001
• Status: Completed
• Phase: Phase 1
• Start date: November 2015
• Est. completion date: October 2020

Study information

• Verified date: June 2022
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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