- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02047344
Efficacy, Safety and Pharmacokinetics Study of Antroquinonol to Treat NSCLC
December 11, 2019 updated by: Golden Biotechnology Corporation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kaohsiung, Taiwan, 88301
- Chang Gung Memorial Hospital-Kaohsiung Medical Center
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Tainan, Taiwan, 704
- National Cheng Kung University Hospitail
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Taipei, Taiwan
- Tri Service General Hospital
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Arizona
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Tucson, Arizona, United States, 85715
- Arizona Clinical Research Center
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California
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San Francisco, California, United States, 94115
- UCSF
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Maryland
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Baltimore, Maryland, United States, 21287
- John Hopkins University
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Salisbury, Maryland, United States, 21801
- Peninsula Regional Med Center
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health System
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Pennsylvania
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Sayre, Pennsylvania, United States, 18840
- Guthrie Clinic, Ltd
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival Rate
Time Frame: 12 weeks
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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.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax
Time Frame: 8 hours
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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.
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8 hours
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Disease Control Rate (DCR)
Time Frame: 12 weeks
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the proportion of patients with a documented CR, PR and SD during the first 12 week treatment cycle according to RECIST version 1.1.
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12 weeks
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T½: the Time Required for a Quantity to Reduce to Half Its Initial Value
Time Frame: 8 hours
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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
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8 hours
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: 12 weeks
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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.
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12 weeks
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Overall Survival
Time Frame: up to week 48
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the time from the date of first administration of study drug to death from any cause
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up to week 48
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Howard Cheng, Ph.D., Golden Biotechnology Corp.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (ACTUAL)
December 7, 2018
Study Completion (ACTUAL)
December 7, 2018
Study Registration Dates
First Submitted
January 16, 2014
First Submitted That Met QC Criteria
January 26, 2014
First Posted (ESTIMATE)
January 28, 2014
Study Record Updates
Last Update Posted (ACTUAL)
December 26, 2019
Last Update Submitted That Met QC Criteria
December 11, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GHNSCLC-2 001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
need DMC proved
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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