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FN-1501 for Acute Myelogenous Leukemia
Phase 1
Waitlist Available
Research Sponsored by Shanghai Fosun Pharmaceutical Development Co, Ltd.
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 during the first year.
Awards & highlights
Study Summary
A Phase 1 Study to Evaluate FN-1501 Monotherapy in Patients With Advanced Solid Tumors and R/R AML
Eligible Conditions
- Cancer
- Solid Tumors
- Acute Myelogenous Leukemia
- Acute Myeloid Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the first year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the first year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)
Secondary outcome measures
Apparent volume of distribution (Vd)
Area under concentration-time curve from 0 to 24 hours (AUC(0-24))
Area under the plasma concentration time curve from zero to infinity (AUC0-∞)
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: FN-1501Experimental Treatment1 Intervention
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Who is running the clinical trial?
Shanghai Fosun Pharmaceutical Development Co, Ltd.Lead Sponsor
4 Previous Clinical Trials
816 Total Patients Enrolled
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.Lead Sponsor
14 Previous Clinical Trials
5,018 Total Patients Enrolled
Ai-Min Hui, MD, PhDStudy DirectorShanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Frequently Asked Questions
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