Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

Kyowa Kirin

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Drug: Exemestane; Drug: KHK2375

Study type: Interventional

Funder types: Industry

Identifiers

NCT02623751

2375-001

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Female

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

KHK2375 PO and Exemestane PO

Experimental group

Description:

KHK2375 and Exemestane

Treatment:

Drug: Exemestane

Drug: KHK2375