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

Study identifier:D8220C00001

ClinicalTrials.gov identifier:NCT03198650

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

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

Medical condition

Part1: Advanced B-cell malignancies

Phase

Phase 1

Healthy volunteers

No

Study drug

Acalabrutinib, Obinutuzumab

Sex

All

Actual Enrollment

35

Study type

Interventional

Age

20 Years - 120 Years

Date

Study Start Date: 27 Jun 2017
Primary Completion Date: 27 Oct 2022
Estimated Study Completion Date: 13 Dec 2024

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria