A Phase 1 Study of Acalabrutinib in Japanese Adult Patients With Advanced B-cell Malignancies

Summary

This is a multicenter, open-label Phase 1 study of acalabrutinib, a selective and irreversible Bruton's tyrosine kinase inhibitor, in Japanese adult patients with advanced B-cell malignancies. This study is divided into 3 parts: Part 1 (dose-confirmation phase), Part 2 (dose-expansion phase) and Part 3 (dose-confirmation phase for combination therapy).

Timeline

Start

2017-06-27

Primary completion

2022-10-27

Completion

2025-09-25

Publications

• Takizawa J, Teshima T, Ennishi D, Ichikawa S, Suzuki R, Kojima A, Takahashi Y, Hayashi N, Kawasumi H, Murayama K, Cheung P, Kawata T, Izutsu K. Safety and efficacy of acalabrutinib and obinutuzumab in treatment-naive chronic lymphocytic leukemia: a Japanese phase 1 study. Leuk Lymphoma. 2024 Nov;65(11):1586-1594. doi: 10.1080/10428194.2024.2370436. Epub 2024 Jul 1.

Drugs

Indications