Non-small Cell Lung Cancer Stage IVPhase 2NCT02047344
Efficacy, Safety and Pharmacokinetics Study of Antroquinonol to Treat NSCLC
A Phase 2 study testing Antroquinonol in people with Non-small Cell Lung Cancer Stage IV, run by Golden Biotechnology Corporation at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Stage IV
- What is being tested?
- Antroquinonol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Oct 2013to 7 Dec 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States7 sites
John Hopkins University
Baltimore, Maryland, 21287
Rush University Medical Center
Chicago, Illinois, 60612
Henry Ford health system
Detroit, Michigan, 48202
Peninsula Regional Med Center
Salisbury, Maryland, 21801
UCSF
San Francisco, California, 94115
Guthrie Clinic, Ltd
Sayre, Pennsylvania, 18840
Arizona Clinical Research Center
Tucson, Arizona, 85715
Taiwan3 sites
Chang Gung Memorial Hospital-Kaohsiung medical center
Kaohsiung City, 88301
National Cheng Kung University Hospitail
Tainan, 704
Tri Service General Hospital
Taipei
About this study
Official title: 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
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.
Read the detailed description
- 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.
- 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.
- 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.
- 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.
- 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.
- Overall survival (OS) defined as the time from randomization to death from any cause.
- Time to progression (TTP) defined as the time from randomization to objective tumor progression by RECIST version 1.1.
- Conditions
- Non-small Cell Lung Cancer Stage IV
- Being tested
- Antroquinonol
- Keywords
- NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntroquinonolDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Antroquinonol (Hocena) | Experimental | 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. Receives: Drug: Antroquinonol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival Rate
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.
Measured: 12 weeks
Secondary outcomes (3)
Cmax
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.
Measured: 8 hours
Disease Control Rate (DCR)
the proportion of patients with a documented CR, PR and SD during the first 12 week treatment cycle according to RECIST version 1.1.
Measured: 12 weeks
T½: the Time Required for a Quantity to Reduce to Half Its Initial Value
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
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startOct 2013
- Primary completion7 Dec 2018
- Study completion7 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung Cancer Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Golden Biotechnology Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Responsible party
- Sponsor
- Investigators
- Howard Cheng, Ph.D., Study director, Golden Biotechnology Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047344
- Sponsor's protocol ID
- GHNSCLC-2 001
- Status last verified
- Dec 2019
- First submitted
- 16 Jan 2014
- Last updated
- 26 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: need DMC proved
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02047344
- Acronym / sponsor ID
- GHNSCLC-2 001
- Conditions
- Non-small Cell Lung Cancer Stage IV
- Keywords
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Golden Biotechnology CorporationIndustry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Study start
- Oct 2013
- Primary completion
- 7 Dec 2018 (actual)
- Study completion
- 7 Dec 2018 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Posted 26 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
- 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.
- 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.
- Overall survival (OS) defined as the time from randomization to death from any cause.
- Time to progression (TTP) defined as the time from randomization to objective tumor progression by RECIST version 1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antroquinonol (Hocena) | Experimental | Drug: Antroquinonolpatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntroquinonolAlso: Hocenapatients 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. | Drug | Antroquinonol (Hocena) |
Primary outcome
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.
3 secondary outcomes
Cmax
Time frame: 8 hours
Disease Control Rate (DCR)
Time frame: 12 weeks
T½: the Time Required for a Quantity to Reduce to Half Its Initial Value
Time frame: 8 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. need DMC proved
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Cheng, Ph.D. study director
Golden Biotechnology Corp.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antroquinonol in people with Non-small Cell Lung Cancer Stage IV, run by Golden Biotechnology Corporation at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival Rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.