An Open-label Phase I Study of Orally Available Novel Small-molecule Fibroblast Growth Factor Receptors (FGFR) 1,2,3 and 4 Inhibitor, ASP5878 at Single and Multiple Doses in Patients With Solid Tumors
NCT02038673 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86
Last updated 2024-10-31
Summary
The objectives of this study are to determine the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of oral ASP5878 in participants with solid tumors.
Conditions
Interventions
- DRUG
-
ASP5878
oral
Sponsors & Collaborators
-
Astellas Pharma Global Development, Inc.
collaborator INDUSTRY -
Astellas Pharma Inc
lead INDUSTRY
Principal Investigators
-
Medical Director · Astellas Pharma Inc
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-11-05
- Primary Completion
- 2017-07-19
- Completion
- 2017-07-19
- FDA Drug
- Yes
Countries
- United States
- Japan
- South Korea
- Taiwan
Study Locations
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