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Trial record 7 of 9 for:    antroquinonol

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

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ClinicalTrials.gov Identifier: NCT03823352
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Golden Biotechnology Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Drug: Antroquinonol Phase 2

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.

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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)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Antroquinonol
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.
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.
Other Name: Hocena




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of Participants alive at 4weeks [ Time Frame: 4 weeks ]
    patients' situation

  2. Number of Participants alive at 24 weeks [ Time Frame: 24 weeks ]
    patients' situation



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of relapsed AML after at least 1 chemotherapy regimen or at initial diagnosis when no intensive treatment possible (based on standard criteria).
  2. Men and women 18 to 70 years of age.
  3. ECOG performance status = 0 or 1.
  4. Ability to comply with the study requirements and give written informed consent.
  5. Expected survival more than 3 months.
  6. Patients with preserved reproductive potential agree to use, with their partner, adequate contraception throughout the study and for 30 days thereafter (contraceptive methods with reliability greater than 90%: cervical caps with spermicide, diaphragms with spermicide, condoms with intravaginal spermicide, non-hormonal intrauterine devices), or true sexual abstinence.

Exclusion Criteria:

  1. Acute promyelocytic leukemia (APL).
  2. Hemoglobin ≤ 7g/dL or platelet ≤ 50,000.
  3. Abnormal liver and renal function:

    • Total bilirubin > 2 mg/dL;
    • AST and ALT > 2.5 × ULN;
    • Creatinine > 1.5 × ULN, OR creatinine clearance < 50 mL/min/1.73m2.
  4. The subject has not recovered to grade ≤ 1 adverse events due to investigational or chemotherapeutic drugs or stem cell transplantation which were administered > 4 weeks prior to study enrollment.
  5. Patient who has had in the past 3 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ ductal carcinoma of the breast.
  6. Subjects with any serious active infection (i.e., requiring an intravenous antibiotic, antifungal, or antiviral agent).
  7. Subjects with known human immunodeficiency virus, active hepatitis B or C.
  8. Subjects who have any other life-threatening illness or organ system dysfunction, which in the opinion of the Investigator, would either compromise subject safety or interfere with the evaluation of the safety of the study drug.
  9. Known or suspected substance abuse or alcohol abuse.
  10. Patients with history of seizure disorders or central nervous system leukemia.
  11. Patients with uncontrolled, intercurrent illness including, but not limited to, symptomatic neurological illness; active, uncontrolled, systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; significant pulmonary disease or hypoxia; or psychiatric illness/social situations that would limit compliance with study requirements.
  12. Inability to swallow oral medications or a recent acute gastrointestinal disorder with diarrhea e.g., Crohn's disease, malabsorption, or CTCAE Grade > 2 diarrhea of any etiology at baseline.
  13. Prior major surgery or trauma within 28 days prior to first dose of study drug.
  14. A positive urine pregnancy test (strip) for female patients of childbearing potential.

Information from the National Library of Medicine

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


Locations
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Russian Federation
City Clinical Hospital n.a. S.P.Botkin Recruiting
Moscow, Russian Federation, 125101
Contact: Olga Vinogradova    8(499)490-0303    olgavinz@mail.ru   
Sponsors and Collaborators
Golden Biotechnology Corporation

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Responsible Party: Golden Biotechnology Corporation
ClinicalTrials.gov Identifier: NCT03823352    
Other Study ID Numbers: GHAML-2-001
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Ubiquinone
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs