NCT03823352

Evaluate Efficacy and Safety/Tolerability Profiles of Antroquinonol in Acute Myeloid Leukemia (AML) Adult Patients

Open-label, Non-randomized, Phase IIa Study to Evaluate Efficacy and Safety/Tolerability Profiles of Antroquinonol in Adult Patients With Relapsed Acute Myeloid Leukemia (AML) or at Initial Diagnosis When no Intensive Treatment is Possible

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Golden Biotechnology Corporation · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The given pilot clinical trial of a medicinal product for medical use, is held to evaluate preliminary efficacy and safety/tolerability profiles of antroquinonol in adult patients with relapsed AML or at initial diagnosis when no intensive treatment is possible.

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-02-20
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2019-01-30
• Last updated: 2021-02-03

Locations

2 sites across 1 country: Russia