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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer Stage IV
Intervention Drug: Antroquinonol
Enrollment 31
Recruitment Details Unselected KRAS-positive and KRAS-negative patients with stage IV (including pleural effusion) non squamous NSCLC and radiologically-confirmed disease progression following greater than or equal to two, but less than or equal to four, prior lines of systemic anti cancer therapy.
Pre-assignment Details Written informed consent was obtained from all patients before initiating screening. The screening period was up to 42 days in duration (Days 42 to 1) for K-Ras testing result, if no history k-Ras result.
Arm/Group Title K-Ras Negative K- Ras Mutant
Hide Arm/Group Description Fresh or archival biopsy tissue to determine KRAS is not mutant. Fresh or archival biopsy tissue to determine KRAS is mutant.
Period Title: Overall Study
Started 16 [1] 15
Completed 16 15
Not Completed 0 0
[1]
one patient is not evaluable in process. however, evaluable to safety report.
Arm/Group Title K-Ras Negative K- Ras Mutant Total
Hide Arm/Group Description Fresh or archival biopsy tissue to determine KRAS is not mutant. Patients will receive one 12 week cycle of antroquinonol 200 mg t.i.d. or until disease progression. Fresh or archival biopsy tissue to determine KRAS is mutant. Patients will receive one 12 week cycle of antroquinonol 200 mg t.i.d. or until disease progression. Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  40.0%
3
  20.0%
9
  30.0%
>=65 years
9
  60.0%
12
  80.0%
21
  70.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
4
  26.7%
7
  46.7%
11
  36.7%
Male
11
  73.3%
8
  53.3%
19
  63.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Asian
8
  53.3%
1
   6.7%
9
  30.0%
Black or African American
1
   6.7%
1
   6.7%
2
   6.7%
White
6
  40.0%
13
  86.7%
19
  63.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
United States
7
  46.7%
14
  93.3%
21
  70.0%
Taiwan
8
  53.3%
1
   6.7%
9
  30.0%
ECOG performance status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Fully active 10 1 11
Restricted in physically strenuous activity 4 12 16
Capable of all selfcare more than 50% work 1 2 3
1.Primary Outcome
Title Progression Free Survival Rate
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Defined as the proportion of patients alive and progression free at Week 12.
Arm/Group Title Progression-free Survival Rate/KRAS Negative Group Progression-free Survival Rate/KRAS Mutant Group
Hide Arm/Group Description:
200mg TID for treating KRAS negative patients 12 weeks
200mg TID for treating KRAS negative patients 12 weeks
Overall Number of Participants Analyzed 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
4
  26.7%
0
   0.0%
2.Secondary Outcome
Title Cmax
Hide Description 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.
Time Frame 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
There were 22 patients with reported concentration data who were eligible for the PK population.
Arm/Group Title Antroquinonol (Hocena) Antroquinonol Day 28
Hide Arm/Group Description:
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.
continue use Antroquinonol for 28 Days
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: ng/mL
276.87  (211.162) 393.55  (315.434)
3.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description the proportion of patients with a documented CR, PR and SD during the first 12 week treatment cycle according to RECIST version 1.1.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
26 patients can be run the full analysis
Arm/Group Title Non- Prior Chemotherapies One Line Failed Prior Chemotherapies Two Lines Failed Prior Chemotherapies More Than Two Lines Failed Prior Chemotherapies
Hide Arm/Group Description:
Patient without any chemotherapy before join Study
Patient join with One line failed prior chemotherapies
Patients join with two lines failed prior chemotherapies
patient failed more than two line chemotherapies before join.
Overall Number of Participants Analyzed 5 3 7 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40
(5.3 to 85.3)
0
(0 to 70.8)
42.9
(9.9 to 81.6)
72.7
(39.0 to 94.0)
4.Secondary Outcome
Title T½: the Time Required for a Quantity to Reduce to Half Its Initial Value
Hide Description 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
Time Frame 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Antroquinonol (Hocena) Antroquinonol Day 28
Hide Arm/Group Description:
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.
continue use Antroquinonol for 28 Days
Overall Number of Participants Analyzed 22 22
Mean (Inter-Quartile Range)
Unit of Measure: hours
3
(0.5 to 4)
2
(0.5 to 4)
5.Other Pre-specified Outcome
Title Objective Response Rate (ORR)
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
full sey analysis group
Arm/Group Title Antroquinonol (Hocena)
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: patients
0
6.Other Pre-specified Outcome
Title Overall Survival
Hide Description the time from the date of first administration of study drug to death from any cause
Time Frame up to week 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non- Prior Chemotherapies One Line Failed Prior Chemotherapies Two Lines Failed Prior Chemotherapies More Than Two Lines Failed Prior Chemotherapies
Hide Arm/Group Description:
Patient without any chemotherapy before join Study
Patient join with One line failed prior chemotherapies
Patients join with two lines failed prior chemotherapies
patient failed more than two line chemotherapies before join.
Overall Number of Participants Analyzed 5 3 7 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
week 12
60
(12.6 to 88.2)
100
(100 to 100)
100
(100 to 100)
90.9
(50.8 to 98.7)
week 48
0
(0 to 0)
100
(100 to 100)
28.6
(4.1 to 61.2)
39.3
(7.3 to 71.6)
Time Frame AEs collected for up to 48 weeks of the study from the time the patient signed the informed consent.
Adverse Event Reporting Description Patients were followed for AEs from the date of informed consent until resolution or stabilization, alternative treatment for NSCLC was started 6 months after last dose of study drug, or loss to follow-up, whichever occurred first. In the event of serious or study drug-related toxicities, the patient was followed until resolution or stabilization. Safety follow up data was collected by telephone contact every 3 months after the EOS visit.
 
Arm/Group Title Antroquinonol (Hocena)
Hide Arm/Group Description 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.
All-Cause Mortality
Antroquinonol (Hocena)
Affected / at Risk (%)
Total   14/31 (45.16%)    
Hide Serious Adverse Events
Antroquinonol (Hocena)
Affected / at Risk (%) # Events
Total   12/31 (38.71%)    
Cardiac disorders   
Cardiac disorders  1 [1]  2/31 (6.45%)  3
Gastrointestinal disorders   
Gastrointestinal disorders  1 [2]  2/31 (6.45%)  2
General disorders   
General disorders and administration site conditions  1 [3]  2/31 (6.45%)  2
Infections and infestations   
Infections and infestations  1 [4]  4/31 (12.90%)  4
Metabolism and nutrition disorders   
Metabolism and nutrition disorders  1 [5]  2/31 (6.45%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps)  1 [6]  3/31 (9.68%)  3
Nervous system disorders   
Nervous system disorders  1 [7]  1/31 (3.23%)  1
Renal and urinary disorders   
Renal and urinary disorders  1 [8]  2/31 (6.45%)  4
Respiratory, thoracic and mediastinal disorders   
Respiratory, thoracic and mediastinal disorders  1 [9]  5/31 (16.13%)  5
1
Term from vocabulary, MedDRA version 17.1
Indicates events were collected by systematic assessment
[1]
Atrial fibrillation Cardiac arrest Tachycardia
[2]
Diarrhoea Intestinal obstruction
[3]
Death Disease progression
[4]
Pneumonia Pyelonephritis acute
[5]
Dehydration Hyponatraemia
[6]
Malignant neoplasm progression Metastases to central nervous system
[7]
Dizziness
[8]
Haematuria Hydronephrosis Ureteric stenosis Urinoma
[9]
Acute respiratory failure Dyspnoea Pulmonary oedema Respiratory distress
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Antroquinonol (Hocena)
Affected / at Risk (%) # Events
Total   31/31 (100.00%)    
Cardiac disorders   
Tachycardia  1  2/31 (6.45%)  5
Gastrointestinal disorders   
Gastrointestinal disorders  1 [1]  30/31 (96.77%)  30
General disorders   
General disorders and administration site conditions  1 [2]  20/31 (64.52%)  20
Infections and infestations   
Infections and infestations  1 [3]  6/31 (19.35%)  6
Investigations   
Investigations  1 [4]  6/31 (19.35%)  6
Metabolism and nutrition disorders   
Metabolism and nutrition disorders  1 [5]  11/31 (35.48%)  11
Musculoskeletal and connective tissue disorders   
Musculoskeletal and connective tissue disorders  1 [6]  8/31 (25.81%)  8
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps)  1 [7]  4/31 (12.90%)  4
Nervous system disorders   
Nervous system disorders  1 [8]  11/31 (35.48%)  11
Psychiatric disorders   
Psychiatric disorders  1 [9]  4/31 (12.90%)  4
Renal and urinary disorders   
Renal and urinary disorders  1 [10]  4/31 (12.90%)  4
Respiratory, thoracic and mediastinal disorders   
Respiratory, thoracic and mediastinal disorders  1 [11]  17/31 (54.84%)  17
1
Term from vocabulary, MedDRA version 17.1
Indicates events were collected by systematic assessment
[1]
Abdominal pain Abdominal pain upper Diarrhoea Flatulence Nausea Vomiting
[2]
Catheter site pain Chest pain Fatigue Influenza like illness
[3]
Pneumonia
[4]
Urine analysis abnormal Weight decreased
[5]
Decreased appetite Dehydration Hypomagnesaemia
[6]
Musculoskeletal pain Pain in extremity
[7]
Malignant neoplasm progression
[8]
Dizziness Headache Neuropathy peripheral
[9]
Insomnia
[10]
Haematuria
[11]
Acute respiratory failure Cough Dyspnoea Nasal congestion Pleural effusion Pneumothorax
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Howard Cheng
Organization: Golden Biotechnology Corp.
Phone: +886-2-28086006
EMail: howard@goldenbiotech.com
Layout table for additonal information
Responsible Party: Golden Biotechnology Corporation
ClinicalTrials.gov Identifier: NCT02047344    
Other Study ID Numbers: GHNSCLC-2 001
First Submitted: January 16, 2014
First Posted: January 28, 2014
Results First Submitted: September 16, 2019
Results First Posted: December 26, 2019
Last Update Posted: December 26, 2019