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ACTIVE NOT RECRUITING
NCT03198650
PHASE1

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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).

Official title: A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Acalabrutinib, a Selective and Irreversible Bruton's Tyrosine Kinase Inhibitor, in Japanese Adult Patients With Advanced B-cell Malignancies

Key Details

Gender

All

Age Range

20 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2017-06-27

Completion Date

2025-12-31

Last Updated

2025-10-09

Healthy Volunteers

No

Interventions

DRUG

Acalabrutinib

Acalabrutinib

DRUG

Obinutuzumab

Obinutuzumab

Locations (14)

Research Site

Chiba, Japan

Research Site

Chūōku, Japan

Research Site

Fukuoka, Japan

Research Site

Isehara-shi, Japan

Research Site

Izumo-shi, Japan

Research Site

Matsuyama, Japan

Research Site

Nagoya, Japan

Research Site

Nagoya, Japan

Research Site

Niigata, Japan

Research Site

Okayama, Japan

Research Site

Sapporo, Japan

Research Site

Sendai, Japan

Research Site

Shimotsuke-shi, Japan

Research Site

Suita-shi, Japan