Evaluate Efficacy and Safety/Tolerability Profiles of Antroquinonol in Acute Myeloid Leukemia (AML) Adult Patients
NCT03823352 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2021-02-03
Summary
This is a IIa phase IIa open-label, non-randomized clinical trial of Antroquinonol, capsule, 100 mg (Golden Biotechnology Corporation, Taiwan) in patients with AML.
Conditions
- Leukemia, Myeloid, Acute
Interventions
- DRUG
-
Antroquinonol
Antroquinonol: 100 mg and corn oil 100 mg encapsulated in a gelatin capsule administered orally. Dose will be selected(200mg TID or 300mg TID with SOC) after phase I, then follow up the best dose for 40 Patients for the efficacy.
Sponsors & Collaborators
-
Golden Biotechnology Corporation
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-02-20
- Primary Completion
- 2020-12-31
- Completion
- 2020-12-31
Countries
- Russia
Study Locations
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