Trial · NCT02047344
Efficacy, Safety and Pharmacokinetics Study of Antroquinonol to Treat NSCLC
NCT02047344, Phase 2, Completed, Golden Biotechnology Corporation; results first posted 2019-12-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy, Safety and Pharmacokinetics Study of Antroquinonol to Treat NSCLC. Trials, record NCT02047344. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02047344
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety and Pharmacokinetics Study of Antroquinonol to Treat NSCLC
- NCT number
- NCT02047344
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Golden Biotechnology Corporation
- Conditions
- Non-small Cell Lung Cancer Stage IV
- Interventions
- Antroquinonol
- First posted
- 2014-01-28
- Last updated
- 2019-12-26
- Results first posted
- 2019-12-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival Rate | 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. |
| Secondary | Cmax | 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. |
| Secondary | Disease Control Rate (DCR) | 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. |
| Secondary | T½: the Time Required for a Quantity to Reduce to Half Its Initial Value | 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 |
| Other | Objective Response Rate (ORR) | 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. |
| Other | Overall Survival | up to week 48 | the time from the date of first administration of study drug to death from any cause |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival Rate | 12 weeks | Defined as the proportion of patients alive and progression free at Week 12. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cmax | 8 hours | There were 22 patients with reported concentration data who were eligible for the PK population. | ng/mL | MEAN |
| SECONDARY | Disease Control Rate (DCR) | 12 weeks | 26 patients can be run the full analysis | percentage of participants | NUMBER |
| SECONDARY | T½: the Time Required for a Quantity to Reduce to Half Its Initial Value | 8 hours | hours | MEAN | |
| OTHER_PRE_SPECIFIED | Objective Response Rate (ORR) | 12 weeks | full sey analysis group | patients | NUMBER |
| OTHER_PRE_SPECIFIED | Overall Survival | up to week 48 | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival Rate | Progression-free Survival Rate/KRAS Negative Group | 4 | Participants | ||
| Progression Free Survival Rate | Progression-free Survival Rate/KRAS Mutant Group | 0 | Participants | ||
| Cmax | Antroquinonol (Hocena) | 276.87 | Standard Deviation 211.162 | ng/mL | |
| Cmax | Antroquinonol Day 28 | 393.55 | Standard Deviation 315.434 | ng/mL | |
| Disease Control Rate (DCR) | Non- Prior Chemotherapies | 40 | 95% Confidence Interval 5.3 to 85.3 | percentage of participants | |
| Disease Control Rate (DCR) | One Line Failed Prior Chemotherapies | 0 | 95% Confidence Interval 0 to 70.8 | percentage of participants | |
| Disease Control Rate (DCR) | Two Lines Failed Prior Chemotherapies | 42.9 | 95% Confidence Interval 9.9 to 81.6 | percentage of participants | |
| Disease Control Rate (DCR) | More Than Two Lines Failed Prior Chemotherapies | 72.7 | 95% Confidence Interval 39.0 to 94.0 | percentage of participants | |
| T½: the Time Required for a Quantity to Reduce to Half Its Initial Value | Antroquinonol (Hocena) | 3 | Inter-Quartile Range 0.5 to 4 | hours | |
| T½: the Time Required for a Quantity to Reduce to Half Its Initial Value | Antroquinonol Day 28 | 2 | Inter-Quartile Range 0.5 to 4 | hours |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | K-Ras Negative | 16 | |
| Overall Study | STARTED | K- Ras Mutant | 15 | |
| Overall Study | COMPLETED | K-Ras Negative | 16 | |
| Overall Study | COMPLETED | K- Ras Mutant | 15 | |
| Overall Study | NOT COMPLETED | K-Ras Negative | 0 | |
| Overall Study | NOT COMPLETED | K- Ras Mutant | 0 |
Source ClinicalTrials.gov
Adverse events21
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tachycardia | Cardiac disorders | Antroquinonol (Hocena) | 2 | 31 | 5 |
| other | Gastrointestinal disorders | Gastrointestinal disorders | Antroquinonol (Hocena) | 30 | 31 | 30 |
| other | General disorders and administration site conditions | General disorders | Antroquinonol (Hocena) | 20 | 31 | 20 |
| other | Infections and infestations | Infections and infestations | Antroquinonol (Hocena) | 6 | 31 | 6 |
| other | Investigations | Investigations | Antroquinonol (Hocena) | 6 | 31 | 6 |
| other | Metabolism and nutrition disorders | Metabolism and nutrition disorders | Antroquinonol (Hocena) | 11 | 31 | 11 |
| other | Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Antroquinonol (Hocena) | 8 | 31 | 8 |
| other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Antroquinonol (Hocena) | 4 | 31 | 4 |
| other | Nervous system disorders | Nervous system disorders | Antroquinonol (Hocena) | 11 | 31 | 11 |
| other | Psychiatric disorders | Psychiatric disorders | Antroquinonol (Hocena) | 4 | 31 | 4 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Antroquinonol (Hocena) | 14 | 31 |
| Total, other adverse events | Antroquinonol (Hocena) | 31 | 31 |
| Total, serious adverse events | Antroquinonol (Hocena) | 12 | 31 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Progression-free Survival Rate/KRAS Negative Group vs Progression-free Survival Rate/KRAS Mutant Group: Progression Free Survival Rate |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02047344
GET https://conductscience.org/api/trials/v1/NCT02047344/events?page=2