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Trial record 8 of 9 for:    antroquinonol

Efficacy, Safety and Pharmacokinetics Study of Antroquinonol to Treat NSCLC

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02047344
Recruitment Status : Completed
First Posted : January 28, 2014
Results First Posted : December 26, 2019
Last Update Posted : December 26, 2019
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Golden Biotechnology Corporation

Tracking Information
First Submitted Date  ICMJE January 16, 2014
First Posted Date  ICMJE January 28, 2014
Results First Submitted Date  ICMJE September 16, 2019
Results First Posted Date  ICMJE December 26, 2019
Last Update Posted Date December 26, 2019
Study Start Date  ICMJE October 2013
Actual Primary Completion Date December 7, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2014)
Progression Free Survival Rate [ Time Frame: 12 weeks ]
Tumor response will be assessed at 6 week intervals during the first treatment cycle using the RECIST criteria, version 1.1. Each patient will be assigned one of the following categories: 1) complete response (CR), 2) partial response (PR), 3) stable disease (SD), or 4) progressive disease (PD). Patients who died from any cause or discontinued the study for any reason without a post screening or Week 12 tumor assessment will be considered as failing to respond to treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2019)
  • Cmax [ Time Frame: 8 hours ]
    PK sampling will be performed on Days 0 and 28 in all patients enrolled in Stage 1.PK endpoints will be derived for intensively sampled PK profiles by non compartmental methods and include: Cmax: peak concentration;Ctrough: trough plasma concentration.
  • Disease Control Rate (DCR) [ Time Frame: 12 weeks ]
    the proportion of patients with a documented CR, PR and SD during the first 12 week treatment cycle according to RECIST version 1.1.
  • T½: the Time Required for a Quantity to Reduce to Half Its Initial Value [ Time Frame: 8 hours ]
    PK sampling will be performed on Days 0 and 28 in all patients enrolled in Stage 1.PK endpoints will be derived for intensively sampled PK profiles by T½: terminal half life
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2014)
  • Pharmacokinetic Profiling,Preliminary Efficacy and Safety Tests in T.I.D treatment [ Time Frame: 12 weeks ]
    PK sampling will be performed on Days 0 and 28 in all patients enrolled in Stage 1. Sparse PK sampling will be performed on Days 28, 42, and 56 in all patients enrolled in Stage 2. PK endpoints will be derived for intensively sampled PK profiles by non compartmental methods and include: Cmax: peak concentration;Ctrough: trough plasma concentration; Tmax: peak time;AUC: area under the plasma concentration time curve over the 8 hour dosing interval;T½: terminal half life;Vz/F: apparent volume of distribution during elimination;CL/F: apparent oral clearance;T½, eff: effective half life.
  • Disease Control Rate (DCR) [ Time Frame: up to 48 weeks ]
    the proportion of patients with a documented CR, PR and SD during the first 12 week treatment cycle according to RECIST version 1.1.
Current Other Pre-specified Outcome Measures
 (submitted: December 11, 2019)
  • Objective Response Rate (ORR) [ Time Frame: 12 weeks ]
    Defined as the proportion of patients whose best overall response is either CR or PR according to RECIST version 1.1. The best overall response is the best response recorded during the first 12 week treatment cycle.
  • Overall Survival [ Time Frame: up to week 48 ]
    the time from the date of first administration of study drug to death from any cause
Original Other Pre-specified Outcome Measures
 (submitted: January 26, 2014)
  • Objective Response Rate (ORR) [ Time Frame: 12 weeks ]
    Dfined as the proportion of patients whose best overall response is either CR or PR according to RECIST version 1.1. The best overall response is the best response recorded during the first 12 week treatment cycle.
  • Overall survival (OS) [ Time Frame: Up to 48 weeks ]
    Defined as the time from randomization to death from any cause.
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety and Pharmacokinetics Study of Antroquinonol to Treat NSCLC
Official Title  ICMJE A Single-Arm, Open-Label, Phase II Trial Evaluating the Efficacy, Safety and Pharmacokinetics of Antroquinonol in Patients With Stage IV (Including Pleural Effusion) Non Squamous NSCLC Who Have Failed Two Lines of Anti-Cancer Therapy
Brief Summary This is a single arm, open label, Phase II study in KRAS-positive and KRAS-negative patients with stage IV (including pleural effusion) non squamous NSCLC who have failed two lines of anti-cancer therapy. A maximum of 60 evaluable patients with NSCLC will receive antroquinonol, of which 30 patients will be KRAS-positive and 30 patients KRAS-negative. An evaluable patient will have received at least one dose of antroquinonol and have a valid baseline tumor assessment. Enrollment will continue until the target number of evaluable patients has been enrolled.
Detailed Description
  1. Progression free survival rate at 12 weeks, defined as the proportion of patients alive and progression free at Week 12. Patients will be progression free if they have no tumor assessments of progressive disease (defined according to RECIST guidelines, version 1.1) at any point from the start of treatment to Week 12.
  2. Objective response rate (ORR), defined as the proportion of patients whose best overall response is either CR or PR according to RECIST version 1.1. The best overall response is the best response recorded during the first 12 week treatment cycle.
  3. Disease control rate (DCR), defined as the proportion of patients with a documented CR, PR and SD during the first 12 week treatment cycle according to RECIST version 1.1.
  4. Duration of overall tumor response (DR), defined as the interval between the date of the first observation of tumor response (CR or PR) and the date of disease progression or death.
  5. Progression free survival defined as the time from randomization to objective tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first.
  6. Overall survival (OS) defined as the time from randomization to death from any cause.
  7. Time to progression (TTP) defined as the time from randomization to objective tumor progression by RECIST version 1.1.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer Stage IV
Intervention  ICMJE Drug: Antroquinonol
patients will receive one 12 week cycle of antroquinonol 200 mg t.i.d. or until disease progression, unacceptable toxicity, non compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first.
Other Name: Hocena
Study Arms  ICMJE Experimental: Antroquinonol (Hocena)
patients will receive one 12 week cycle of antroquinonol 200 mg t.i.d. or until disease progression, 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 Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2019)
31
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2014)
60
Actual Study Completion Date  ICMJE December 7, 2018
Actual Primary Completion Date December 7, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Cytologically or histologically confirmed non squamous NSCLC Stage IV (including pleural effusion).
  • Radiologically confirmed disease progression following two previous lines of anti-cancer therapy, one of which should be a platinum based regimen, OR the patient has refused treatment with approved treatment modalities
  • At least one radiologically measurable target lesion per RECIST version 1.1
  • Fresh or archival biopsy tissue available to determine tumor mutation status
  • Written informed consent that is consistent with International Conference on Harmonisation Tripartite Guideline on Good Clinical Practice guidelines
  • Patient or legally acceptable representative has granted written informed consent before any study specific procedures (including special Screening tests) are performed
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2
  • Hemoglobin ≥ 9.0 g/dL; platelets ≥ 100 x 109/L; absolute neutrophil count ≥ 1.5 x 109/L without the use of hematopoietic growth factors
  • Bilirubin and creatinine less than 2 × upper limit of normal (ULN) for the institution
  • Albumin ≥ 2.5 mg/dL
  • Aspartate aminotransferase and alanine aminotransferase less than 5 × ULN for the institution
  • Prothrombin time less than 1.5 × ULN for the institution
  • Potassium, magnesium and phosphorus within the normal range for the institution (supplementation is permissible)
  • Recovery to Grade 1 or baseline of any toxicities due to prior treatments, excluding alopecia

Exclusion Criteria:

  • Chemo-, hormone- or immunotherapy, within 4 weeks or within less than four half lives of the date of first administration of study drug and/or persistence of toxicities of prior anti-cancer therapies which are deemed to be clinically relevant
  • Radiotherapy within the past 2 weeks prior to date of first administration of study drug
  • Previous treatment with an histone deacetylase inhibitor or an epidermal growth factor receptor inhibitor within at least 4 weeks of the date of first administration of study drug
  • Treatment with any drug(s) known to be an inhibitor or inducer of cytochrome P450 (CYP)2C19, CYP3A4, CYP2C8, and CYP2E1, within 14 days of the date of first administration of study drug
  • Brain metastases, which are symptomatic; patients with treated, brain metastases are eligible with stable brain disease for at least 4 weeks without the requirement for steroids or anti epileptic therapy
  • Inability to swallow oral medications or a recent acute gastrointestinal disorder with diarrhea e.g., Cohn's disease, malabsorption, or Common Terminology Criteria for Adverse Event (CTCAE) Grade > 2 diarrhea of any etiology at baseline
  • Other malignancies diagnosed within the past five years (other than curatively treated cervical cancer in situ), non melanoma skin cancer, superficial bladder tumors Ta (non invasive tumor) and TIS (carcinoma in situ)
  • Patients with any serious active infection (i.e., requiring an intravenous antibiotic, antifungal, or antiviral agent)
  • Patients with known human immunodeficiency virus, active hepatitis B or active hepatitis C
  • Patients who have any other life threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the study drug
  • Known or suspected substance abuse or alcohol abuse
  • Pregnancy or breast feeding
  • History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association functional classification of three
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02047344
Other Study ID Numbers  ICMJE GHNSCLC-2 001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: need DMC proved
Responsible Party Golden Biotechnology Corporation
Study Sponsor  ICMJE Golden Biotechnology Corporation
Collaborators  ICMJE ICON Clinical Research
Investigators  ICMJE
Study Director: Howard Cheng, Ph.D. Golden Biotechnology Corp.
PRS Account Golden Biotechnology Corporation
Verification Date December 2019

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