NCT02476539

Study Evaluating Hemay022 In Subjects With HER2-Positive Advanced Breast Cancer

An Ascending Single and Multiple Dose Study of the Pharmacokinetics, Safety and Tolerability of the Irreversible Epidermal Growth Factor Receptor Inhibitor Hemay022 in Patients With HER2-Positive Advanced Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Tianjin Hemay Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purposes of this study are to assess the safety, tolerability and pharmacokinetics of Hemay022. The secondary purpose of this study is to assess the efficacy of Hemay022 in the treatment of HER2-positive advanced breast cancer. The study will be conducted in two parts. Part one, trial will be conducted in 18-30 subjects to determine safety and tolerability of Hemay022 in patients with HER2-positive advanced breast cancer. Part two, approximately 27 additional subjects with HER2-positive advanced breast cancer, are included to better define the tolerability and preliminary efficacy of Hemay022.

Detailed description

This is a phaseⅠsequential-group study of ascending single and multiple oral doses administered to subjects with HER2-Positive Advanced Breast Cancer. Each subject will receive a single dose of Hemay022, followed by a 1-week observation period, and then will receive Hemay022 administered once daily by mouth for 28 days. Each cycle consist of 28 days. Subjects will be enrolled in groups of 3 to 6. Depending on the safety and activity profile observed during the dose escalation phase, the dose selected for Part 2 may be adjusted. Part 2 is an extension part of three dose groups.

Conditions

• HER2 Positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Hemay022

Timeline

• Start date: 2015-10-14
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2015-06-19
• Last updated: 2024-03-01

Locations

1 site across 1 country: China