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Tyrosine Kinase Inhibitor
Study to Investigate the Absorption, Metabolism and Excretion of [14C] ASP2215 in Patients With Advanced Solid Tumors
Phase 1
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 15 - 46
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled gilteritinib, in particular, the routes of excretion and extent of metabolism of gilteritinib following administration of a single dose of 14C-labeled gilteritinib after repeated doses of gilteritinib. This study will also evaluate the safety of repeated oral administration of gilteritinib in subjects with advanced solid tumors as well as identify the metabolic profile of gilteritinib in plasma, urine and feces after a single oral dose of 14C-labeled gilteritinib.
Eligible Conditions
- Gilteritinib Pharmacokinetics
- Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 15 - 46
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 15 - 46
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cumulative excretion of 14C-labeled gilteritinib (radioactivity in feces)
Cumulative excretion of 14C-labeled gilteritinib (radioactivity in urine)
Excretion rate of 14C-labeled gilteritinib (radioactivity in feces)
+10 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: gilteritinib and 14C-labeled gilteritinibExperimental Treatment2 Interventions
Gilteritinib will be taken once daily on study days 1 through 14 and days 16 through 47. On day 15, each participant will be given a single dose of 14C-labeled gilteritinib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gilteritinib
FDA approved
Gilteritinib
FDA approved
Find a Location
Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
200 Previous Clinical Trials
122,178 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,905 Previous Clinical Trials
8,091,483 Total Patients Enrolled