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Trial record 9 of 9 for:    antroquinonol

Determine MTD and to Evaluate pk, Safety/Tolerability and Efficacy Profiles of Hocena® in NSCLC Subjects (Hocena)

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ClinicalTrials.gov Identifier: NCT01134016
Recruitment Status : Completed
First Posted : May 31, 2010
Results First Posted : February 27, 2014
Last Update Posted : June 21, 2016
Sponsor:
Collaborator:
PharmaNet
Information provided by (Responsible Party):
Golden Biotechnology Corporation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer
Intervention Drug: Antroquinonol
Enrollment 13
Recruitment Details A total of 13 patients were enrolled and treated: 1 patient each received 50, 100, 200, and 300 mg, 4 patients received 450 mg, and 5 patients received 600 mg. The recruitment period is from 19 Jan 2010 to 13 Dec 2012 in list two medical center, Taiwan.
Pre-assignment Details This was an open-label, non-randomized, dose escalation, PK study to determine the MTD and DLTs and to explore the PK, safety/tolerability, and preliminary efficacy profiles of antroquinonol.
Arm/Group Title Antroquinonol
Hide Arm/Group Description

Safety dose finding from 50mg to 600mg

Antroquinonol : Dosage form: 50 mg and 100 mg capsules

Dosage levels: 50 mg, 100 mg, 200 mg, 300mg, 450mg and 600mg ( 6 cohorts)

Frequency: take daily for 4 weeks per subject per dosage level

Period Title: Overall Study
Started 13
Completed 10
Not Completed 3
Arm/Group Title Antroquinonol
Hide Arm/Group Description

Safety dose finding from 50mg to 600mg

Antroquinonol : Dosage form: 50 mg and 100 mg capsules

Dosage levels: 50 mg, 100 mg, 200 mg, 300mg, 450mg and 600mg ( 6 cohorts)

Frequency: take daily for 4 weeks per subject per dosage level

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
A total of 13 patients were enrolled in this study
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  53.8%
>=65 years
6
  46.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
6
  46.2%
Male
7
  53.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
13
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 13 participants
13
Height  
Mean (Full Range)
Unit of measure:  Cm
Number Analyzed 13 participants
159.76
(143 to 172)
Weight  
Mean (Full Range)
Unit of measure:  Kg
Number Analyzed 13 participants
64.57
(45.7 to 79.2)
BMI  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 13 participants
25.214
(21.15 to 32.97)
1.Primary Outcome
Title To Determind the Maximum Tolerable Dose for Antroquinonol
Hide Description

The study design consisted of 2 phases, the accelerated titration phase and the standard titration phase.

During the accelerated titration phase, patients were enrolled in a cohort of 1 new patient for each dose level and treated for 4 weeks at that level. Any DLT or instance of MT during any 4 week treatment at any dose level led to the initiation of standard titration (3+3) phase.

If none of the first 3 patients experienced any DLT, then dose escalation proceeded for the next cohort of patients. If 1 of 3 patients developed DLT, the cohort was expanded to at most 6 patients (another 3 patients added subsequently). If exactly 1 of the 6 patients experienced DLT, then escalation to the next dose level occurred. If more than 1 patient developed DLT in any dose cohort, the dose escalation was withheld and the prior dose level was considered as the MTD unless the present dose level was level 1

Time Frame DLT is to be observed during 4 week period
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: All patients who received at least 1 dose of antroquinonol.
Arm/Group Title Antroquinonol
Hide Arm/Group Description:
Maximum Tolerable Dose for Antroquinonol
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: mg
600
2.Secondary Outcome
Title Tmax After Dose
Hide Description Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only. Individual serum concentration versus (vs) time curves were plotted in 1 graph by dose level on both linear/linear and log10/linear scales. Mean serum concentration vs time curves were also presented in 1 graph for dose levels on both linear/linear and log10/linear scales.
Time Frame 30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1&28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tmax Day1: 50mg Tmax Day 1: 100 mg Tmax Day 1: 200mg Tmax Day 1: 300mg Tmax Day 1: 450mg Tmax Day 1 :600 mg Tmax Day 28: 50mg Tmax Day 28: 100mg Tmax Day 28: 200 mg Tmax Day 28: 300mg Tmax Day 28: 450mg Tmax Day 28: 600mg
Hide Arm/Group Description:
Patient represent the time to reach the maximum plasma concentration after dose
Patient represent the time to reach the maximum plasma concentration after dose
Patient represent the time to reach the maximum plasma concentration after dose
Patient represent the time to reach the maximum plasma concentration after dose
Patient represent the time to reach the maximum plasma concentration after dose
Patient represent the time to reach the maximum plasma concentration after dose
Patient represent the time to reach the maximum plasma concentration after dose
Patient represent the time to reach the maximum plasma concentration after dose
Patient represent the time to reach the maximum plasma concentration after dose
Patient represent the time to reach the maximum plasma concentration after dose
Patient represent the time to reach the maximum plasma concentration after dose
Patient represent the time to reach the maximum plasma concentration after dose
Overall Number of Participants Analyzed 1 1 1 1 4 5 1 1 1 1 3 3
Median (Full Range)
Unit of Measure: hours
2.00
(2.00 to 2.00)
1.00
(1.00 to 1.00)
10.00
(10.00 to 10.00)
1.13
(1.13 to 1.13)
1.82
(1.08 to 3.97)
3.70
(2.00 to 9.70)
1.92
(1.92 to 1.92)
3.17
(3.17 to 3.17)
4.00
(4.00 to 4.00)
4.05
(4.05 to 4.05)
3.00
(1.07 to 6.20)
3.15
(2.07 to 3.87)
3.Secondary Outcome
Title Half-life Time From Overall Study
Hide Description Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only. Individual serum concentration versus (vs) time curves were plotted in 1 graph by dose level on both linear/linear and log10/linear scales. Mean serum concentration vs time curves were also presented in 1 graph for dose levels on both linear/linear and log10/linear scales.
Time Frame 30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1&28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Half-life Time Day 1:50mg Half-life Time Day 1: 100 mg Half-life Time Day 1: 200mg Half-life Time Day 1: 300mg Half-life Time Day 1: 450 mg Half-life Time Day 1: 600 mg Half-life Time Day 28: 50mg Half-life Time Day 28:100 mg Half-life Time Day 28: 200 mg Half-life Time Day 28: 300 mg Half-life Time Day 28: 450 mg Half-life Time Day 28: 600mg
Hide Arm/Group Description:
The time of plasma concentration drops from maximum to half
The time of plasma concentration drops from maximum to half
The time of plasma concentration drops from maximum to half
The time of plasma concentration drops from maximum to half
The time of plasma concentration drops from maximum to half
The time of plasma concentration drops from maximum to half
The time of plasma concentration drops from maximum to half
The time of plasma concentration drops from maximum to half
The time of plasma concentration drops from maximum to half
The time of plasma concentration drops from maximum to half
The time of plasma concentration drops from maximum to half
The time of plasma concentration drops from maximum to half
Overall Number of Participants Analyzed 1 1 1 1 4 5 1 1 1 1 3 3
Mean (Standard Deviation)
Unit of Measure: hours
2.42 1.30 4.33 1.93 2.38  (1.34) 3.07  (1.52) 1.60 2.34 1.41 2.11 1.81  (0.66) 2.55  (1.30)
4.Secondary Outcome
Title Maximum Plasma Concentration After on Day 1
Hide Description Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.
Time Frame 30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Population: All patients who received at least 1 dose of antroquinonol with sufficient post-dose bio-samples collected for PK profile characterization.
Arm/Group Title Cmax Day 1
Hide Arm/Group Description:
the observed maximum plasma concentration after dosing on Day 1
Overall Number of Participants Analyzed 13
Mean (95% Confidence Interval)
Unit of Measure: Log(mg/ml)
0.504
(0.17 to 0.83)
5.Secondary Outcome
Title Maximum Plasma Concentration After Dosing on Day 28
Hide Description Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.
Time Frame 30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cmax Day 28
Hide Arm/Group Description:
the observed maximum plasma concentration after dosing on Day 28
Overall Number of Participants Analyzed 10
Mean (95% Confidence Interval)
Unit of Measure: log(mg/ml)
0.682
(0.08 to 1.28)
6.Secondary Outcome
Title AUC0-t on Day 1
Hide Description Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.
Time Frame within 30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AUC0-t on Day 1
Hide Arm/Group Description:
truncated area under the plasma concentration-time curve from the beginning of dosing to the last measurable concentration on Day 1
Overall Number of Participants Analyzed 13
Mean (95% Confidence Interval)
Unit of Measure: log(mg*hr/mL)
0.641
(0.16 to 1.12)
7.Secondary Outcome
Title AUC0-t on Day 28
Hide Description Pharmacokinetic samples will be obtained from all the patients in each dose cohort treated in all phases of the study. Patients will only be sampled during their first treatment cycle only.
Time Frame 30 minutes prior to and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 14, and 24 hours after dose of Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AUC0-t on Day 28
Hide Arm/Group Description:
truncated area under the plasma concentration-time curve from the beginning of dosing to the last measurable concentration on Day 28
Overall Number of Participants Analyzed 10
Mean (95% Confidence Interval)
Unit of Measure: log(mg*hr/mL)
0.957
(0.59 to 1.32)
8.Secondary Outcome
Title Number of Participants in the PP Population With Better Than SD at Target Lesion, Better Than Non-CR/Non-PD at Non-target Lesion and no New Lesion
Hide Description

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for overall response by CT: Judgement by total siutation of target, non-target and new lesions.

Meaning of Target lesion: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), Sum down 30% or more from target lesion baseline; Progressive Disease(PD), Sum up at least 20% from smallest value (nadir) and Absolute increase ≥ 5 mm; Stable Disease (SD), Neither enough shrinkage for PR nor enough growth for PD.

non-target lesion: CR: All non-target lesions disappeared and All lymph nodes <10 mm; Non-CR/Non-PD: Non-target lesion(s) still present and Lymph nodes ≥10 mm; PD: Unequivocal progression; New lesion :Unequivocal new cancer lesions Overall SD response should be better than SD at target lesion, better than Non-CR/Non-PD t non-target lesion and no new lesion.

Time Frame pre-screening and end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol (PP) Population: All patients who completed at least 3 cycles of treatment with proper imaging assessment (RECIST).
Arm/Group Title Tumer Responce at Per-protocol (PP) Population
Hide Arm/Group Description:
All patients who completed at least 3 cycles of treatment with proper imaging assessment (RECIST) of tumor size.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
3
9.Secondary Outcome
Title Safety Blood and Urine Test
Hide Description
  1. Hematology laboratory data
  2. Biochemistry laboratory data
  3. Urinalysis
  4. AE; AE not including the natural progress of the underlying disease
  5. Incidence of toxicity ≥ grade 3 according to NCI CTCAE version 4.03
  6. Physical examination
  7. Vital signs changes
  8. Electrocardiogram examination results (including HR, QRS, QT, QTc, RR intervals)
Time Frame pre-screenting and every 14-day period
Outcome Measure Data Not Reported
Time Frame recorded immediatly as AE happen
Adverse Event Reporting Description treatment-emergent adverse events (TEAEs) were reported as determined by the NCI CTCAE, Version 4.03. reported only related to the study drug
 
Arm/Group Title Antroquinonol
Hide Arm/Group Description

Safety dose finding from 50mg to 600mg

Antroquinonol : Dosage form: 50 mg and 100 mg capsules

Dosage levels: 50 mg, 100 mg, 200 mg, 300mg, 450mg and 600mg ( 6 cohorts)

Frequency: take daily for 4 weeks per subject per dosage level

All-Cause Mortality
Antroquinonol
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Antroquinonol
Affected / at Risk (%) # Events
Total   0/13 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Antroquinonol
Affected / at Risk (%) # Events
Total   13/13 (100.00%)    
Gastrointestinal disorders   
diarrhea  1 [1]  12/13 (92.31%)  12
vomiting  1  9/13 (69.23%)  9
nausea  1  7/13 (53.85%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, NCI CTCAE, Version 4
[1]
12 patients, 92.3% [7 patients in grade 1, 53.8%, and 5 patients in grade 2, 38.5%]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
All the PI should grand sponcer's agree to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Howard Cheng, Director of clinical trials
Organization: Golden Biotechnology Corp.
Phone: 886-2808-6006
EMail: howard@goldenbiotech.com.tw
Layout table for additonal information
Responsible Party: Golden Biotechnology Corporation
ClinicalTrials.gov Identifier: NCT01134016    
Other Study ID Numbers: GOLANTA20090911
First Submitted: May 14, 2010
First Posted: May 31, 2010
Results First Submitted: August 12, 2013
Results First Posted: February 27, 2014
Last Update Posted: June 21, 2016