An Open-Label Phase 1 Study of Ceralasertib in Japanese Patients With Advanced Solid Malignancies
NCT05469919 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2024-08-02
Summary
This is a Phase 1, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of ceralasertib in Japanese patients with advanced solid malignancies. Cycle 0 duration is 4 days and each cycle from Cycle 1 has a duration of 28 days.
Conditions
- Advanced Solid Malignancies
Interventions
- DRUG
-
Ceralasertib
Ceralasertib taken orally
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-09
- Primary Completion
- 2023-08-17
- Completion
- 2024-03-12
Countries
- Japan
Study Locations
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