Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Drug: KHK2375; Drug: Exemestane

• Registration Number: NCT02623751
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-08
• Primary Completion: 2020-10
• Study Completion: 2020-10
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-15
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KHK2375 PO and Exemestane PO	KHK2375	KHK2375 and Exemestane
KHK2375 PO and Exemestane PO	Exemestane	KHK2375 and Exemestane

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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