Evaluate Efficacy and Safety/Tolerability Profiles of Antroquinonol in Acute Myeloid Leukemia (AML) Adult Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03823352|
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : May 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid, Acute||Drug: Antroquinonol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients will receive Antroquinonol 200 mg BID on Day 1 for 4 weeks or until transfusion of red blood cell or platelet ≧ 2, unacceptable toxicity, non-compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first.|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||February 20, 2019|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||July 31, 2020|
Patients will receive Antroquinonol 200 mg BID on Day 1 for 4 weeks or until transfusion of red blood cell or platelet ≧ 2, unacceptable toxicity, non-compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first.
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.
Other Name: Hocena
- Complete blood count measurements according International Working Group (IWG) response criteria [ Time Frame: 2 weeks ]Evaluation of preliminary efficacy profile of antroquinonol in adult patients with relapsed AML or at initial diagnosis when no intensive treatment is possible.
- Number of Participants alive at 4weeks [ Time Frame: 4 weeks ]patients' situation
- Number of Participants alive at 24 weeks [ Time Frame: 24 weeks ]patients' situation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823352
|City Clinical Hospital n.a. S.P.Botkin||Recruiting|
|Moscow, Russian Federation, 125101|
|Contact: Olga Vinogradova 8（499）490-0303 email@example.com|