A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of KW-2450 in Combination With Lapatinib and Letrozole in Subjects With Advanced or Metastatic Breast Cancer Whose Tumors Overexpress HER2
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Michael Kurman, MD
Kyowa Hakko Kirin Pharma, Inc.
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|Sylvester Comprehensive Cancer Center||Miami, Florida|
|Breastlink Research Group||Long Beach, California 90250|
|Associates in Hematology-Oncology||Los Angeles, California 90057|
|Clinical Oncology Associates||Farmington Hills, Michigan 48336|