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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

Tracking Information
First Submitted Date  ICMJE January 27, 2019
First Posted Date  ICMJE January 30, 2019
Last Update Posted Date May 14, 2019
Actual Study Start Date  ICMJE February 20, 2019
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate Efficacy and Safety/Tolerability Profiles of Antroquinonol in Acute Myeloid Leukemia (AML) Adult Patients
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Leukemia, Myeloid, Acute
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Antroquinonol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2019)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03823352
Other Study ID Numbers  ICMJE GHAML-2-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Golden Biotechnology Corporation
Study Sponsor  ICMJE Golden Biotechnology Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Golden Biotechnology Corporation
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP