Safety, Tolerability, and Efficacy Study in Subjects With Advanced or Metastatic Breast Cancer

Phase 1

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: KW-2450 in combination with lapatinib and letrozole

• Registration Number: NCT01199367
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

This study will determine the highest dose of KW-2450 in combination with lapatinib and letrozole that can be administered safely to subjects with advanced or metastatic breast cancer and to evaluate its effectiveness.

This study was terminated in Phase 1 and never proceeded to the Phase 2 portion of the study.

Detailed Description

This open-label, sequential, ascending, multi-dose, Phase 1/2 study will enroll up to 198 post-menopausal subjects with advanced or metastatic breast cancer whose tumors overexpress HER2. Subjects at each dose level will receive KW-2450 orally, on a continuous daily schedule in combination with lapatinib and letrozole.

In the Phase 1 portion of the study, dose escalation may proceed once ≥ 3 subjects have completed Day 30. The safety of each dose level will be established prior to enrollment of subjects in the next dose level. Dose escalation will proceed sequentially. Up to 6 subjects may be enrolled at each dose level. Enrollment will proceed until the MTD has been established or the highest dose level has been reached.

The Phase 2 portion of the trial will enroll 168 additional subjects. The dose level will be based on overall safety and tolerability assessments from the Phase 1 portion of the study. The subjects will be randomized into two treatment arms (1) Arm A, KW-2450 plus lapatinib plus letrozole: (2) Arm B, lapatinib plus letrozole.

This study was terminated in Phase 1 and never proceeded to the Phase 2 portion of the study.

Study Timeline

• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Study Start: 2010-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose escallation	KW-2450 in combination with lapatinib and letrozole	-

Primary Outcome Measures

Name	Time	Method
To establish the safety, tolerability, and recommended Phase 2 dose of KW-2450 administered in combination with lapatinib and letrozole in subjects with previously treated or untreated advanced breast cancer.	30 Days

Secondary Outcome Measures

Name	Time	Method
To determine the PK profile of KW-2450, lapatinib, and letrozole when administered together	1 year (or until PD)

Trial Locations

Locations (5)

Associates in Hematology-Oncology; 🇺🇸 Los Angeles, California, United States

Clinical Oncology Associates; 🇺🇸 Farmington Hills, Michigan, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Sylvester Comprehensive Cancer Center; 🇺🇸 Deerfield Beach, Florida, United States

Breastlink Research Group; 🇺🇸 Long Beach, California, United States