Pancreatic NeoplasmPhase 1/2NCT03310632
Determine Function of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic Cancer
A Phase 1/2 study testing Antroquinonol in people with Pancreatic Neoplasm, run by Golden Biotechnology Corporation at 11 sites in 3 countries.
Trial summary
Antroquinonol is proposed for the treatment of neoplasms. The proposed clinical trial is a Phase I/II study designed to evaluate antroquinonol in combination with nab-paclitaxel and gemcitabine in first line treatment naïve subjects with Stage IV metastatic pancreatic carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasm
- What is being tested?
- Antroquinonol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 1 Dec 2017to 2 Jan 2024
- Phase
- Phase 1/2
- 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
- Male and female patients ≥18 years of age.
- Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas, measurable according to the RECIST 1.1.
- Diagnosed with metastatic disease within 6 weeks before enrollment.
- Treatment-naïve patients with metastatic pancreatic adenocarcinoma who have received no previous systemic therapy (except adjuvant or neoadjuvant therapy if progression occurred >6 months from last treatment or surgery, respectively, and no prior nab-paclitaxel).
- Adequate hematologic, hepatic, and renal function, including:
- Hemoglobin ≥9 g/dL
Show all 22Show fewer
- Absolute neutrophil count ≥1500/mm3
- Platelet count ≥100 000/mm3
- Total bilirubin ≤1.25 × upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; for patients with hepatic metastases, ALT and AST ≤5 × ULN
- Albumin ≥3 mg/dL
- Serum creatinine ≤1.5 mg/dL or calculated creatinine clearance ≥50 mL/min as determined by the Cockcroft-Gault equation.
- ECOG performance status of 0 or 1.
- For women of childbearing potential, a negative serum pregnancy test result at Screening.
- Willing to use 2 medically accepted and effective methods of contraception from the list below during the study (both men and women as appropriate) and for 3 months after the last dose of study drug:
- Established use of oral, injected, or implanted hormonal methods of contraception
- Placement of an intrauterine device or intrauterine system
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- Male sterilization (with the appropriate postvasectomy documentation of the absence of sperm in the ejaculate)
- True abstinence (when this is in line with the preferred and usual lifestyle of the patient).
- Patient must be able to provide written informed consent for participation in the study.
- Life expectancy ≥12 weeks as assessed by the Investigator.
Who cannot join
- Islet-cell neoplasms or locally advanced disease.
- Chemo-, hormone-, or immunotherapy or investigational drug at Screening or prior to enrollment.
- Treatment with any drug(s) known to be a strong inhibitor or inducer of CYP2C19,CYP3A4, CYP2C8, and CYP2E1 within 14 days of the date of first administration of study drug and during study treatment.
- Other malignancies diagnosed within the past 5 years (other than curatively treated cervical cancer in situ, nonmelanoma skin cancer, superficial bladder tumors Ta [noninvasive tumor] and TIS [carcinoma in situ], or nonmetastatic prostate cancer Stage 1 to 2, which has been previously treated with surgery or radiation therapy, and serum prostate-specific antigen is within normal limits [test performed within the past 12 months prior to the date of first administration of study drug]).
- Patients with any serious active infection (ie, requiring an IV antibiotic, antifungal, or antiviral agent).
- Patients with known human immunodeficiency virus, active hepatitis B, or active hepatitis C.
Show all 12Show fewer
- 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.
- Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs from study treatment, or compromise the ability of the patient to give written informed consent.
- Inability to swallow oral medications or a recent acute gastrointestinal disorder with diarrhea, (eg, Crohn's disease), malabsorption, or CTCAE Grade >2 diarrhea of any etiology at baseline.
- Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not employing an effective method of contraception.
- Any known hypersensitivity to any component of nab-paclitaxel, gemcitabine, or antroquinonol.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
United States5 sites
Henry Ford Health System
Detroit, Michigan, 48202
Cancer Treatment Centers of America at Southeastern Regional Medical Center
Newnan, Georgia, 30265
Cancer Treatment Centers of America - Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124
Maryland Oncology Hematology
Rockville, Pennsylvania, 20850
Florida Hospital Tampa
Tampa, Florida, 33613
South Korea4 sites
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Inha University Hospital
Incheon, 22322
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 5505
Taiwan2 sites
National Cheng Kung University Hospital
Tainan, Tainan, 704
Taipei Veterans General Hospital
Taipei, Taipei, 11217
About this study
Official title: A Phase I/II Study to Determine the MTD and to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic Cancer
Antroquinonol is proposed for the treatment of neoplasms. The proposed clinical trial is a Phase I/II study designed to evaluate antroquinonol in combination with nab-paclitaxel and gemcitabine in first line treatment naïve subjects with Stage IV metastatic pancreatic carcinoma. The first part of study will focus on the treatment of pancreatic cancer with 200 mg TID and 300 mg TID, clinical treatment duration of 4 weeks, to determine the MTD or MFD (based on PK and capsules strength) of antroquinonol in combination with a standard dose regimen of nab-paclitaxel and gemcitabine. The extended Phase II will focus on the efficacy of antroquinonol with SOC. Safety and pharmacokinetic profiles will be studied in the proposed clinical trial.
Read the detailed description
Golden Biotech are planning a Phase I/II study to determine the maximum tolerable dose (MTD) and to evaluate safety/tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of antroquinonol in combination with nab-paclitaxel-gemcitabine in first line metastatic pancreatic cancer.
Phase I
Run-in DDI and dose escalation:
The dose escalation part of the study will be conducted to characterize the safety of antroquinonol in combination with the standard of care (SOC) (nab-paclitaxel + gemcitabine) and to identify the MTD of antroquinonol in patients with metastatic pancreatic cancer. The MTD is the dose level at which <33% (2/6) of patients experience a DLT. Within the dose escalation part of the study, a total of 6 patients will be enrolled in a run-in DDI portion to assess the effect of antroquinonol (a cytochrome P450 [CYP]3A4/CYP2C8 inhibitor) on the PK of paclitaxel (a CYP3A4/CYP2C8 substrate). Patients within this cohort (Cohort 1) will receive treatment as follows:
- Cycle 0 (28-day cycle): nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 (as per SOC) via intravenous (IV) infusion on Days 1, 8, and 15.
- Cycle 1 (28-day cycle): antroquinonol 200 mg administered TID on Days 1 through 28 and nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 via IV infusion on Days 1, 8, and 15.
Intense PK sampling to assess the PK of paclitaxel will be conducted in Cycles 0 and 1. The primary PK endpoints will include Cmax, AUC0-t, and AUCinf. Available bioanalytical data will be assessed in an ongoing manner to assess the effect of antroquinonol on the systemic exposure (Cmax and AUCs) of paclitaxel. Data will be reviewed by the Safety Monitoring Committee (SMC) prior to enrollment of additional patients into the dose-escalation part of the study.
For Cohort 1, the occurrence of DLTs will be assessed from Day 1 to Day 28 of Cycle 1. If ≤1 patient experiences a DLT, dosing in the dose escalation part will proceed. If ≥2 patients experience a DLT, dosing in the dose escalation part of the study will be discontinued. If ≤1 patient in Cohort 1 experiences a DLT then dosing in Cohort 2 of the dose escalation part will proceed as follows: - All Cycles: antroquinonol 300 mg administered TID on Days 1 through 28 and nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 via IV infusion on Days 1, 8, and 15 (ie, 1 cycle = weekly for 3 weeks, then 1 week off) .
Three patients will be enrolled initially into Cohort 2, these patients will be assessed for DLTs within the first 28-day dosing cycle. This cohort will be expanded to 6 total patients if 1 DLT is observed in the first 3 patients within Cohort 2. If ≤1 DLT is observed at the 300 mg dose then the 300 mg dose will be considered the MFD. If >1 DLT is observed at the 300 mg group then 200 mg will be considered the MTD and/or the SMC will review the available data and determine the MTD/recommended dose (RD).
Patients enrolled into the dose escalation part of the study (Cohorts 1 and 2) will continue to receive treatment with antroquinonol (200 or 300 mg, respectively) in combination with nab-paclitaxel + gemcitabine in 28-day cycles at the discretion of the Investigator without a maximum duration until unacceptable toxicity or progressive disease (PD).
The total number of patients to be entered in the dose escalation part of the study will depend on the emergence of DLTs at each dose level and the total number of dose levels investigated. Up to 12 patients are planned to be treated in the dose-escalation part if no patient needs to be replaced for DLT and safety evaluation.
Phase II
Cohort expansion:
During the cohort expansion part of the study, up to an additional 40 patients will be enrolled at the MTD or MFD/RD. The dose level in the cohort expansion phase will not exceed the MTD, or highest safe dose tested in the dose-escalation phase if MTD is not reached. Patients in the cohort expansion will receive treatment as follows:
- All Cycles: antroquinonol at the MTD or MFD/RD administered TID on Days 1 through 28 and nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 via IV infusion on Days 1, 8, and 15 (ie, 1 cycle = weekly for 3 weeks, then 1 week off) .
Patients enrolled into the cohort expansion part of the study will continue to receive treatment with antroquinonol at the MTD or MFD/RD in combination with nab-paclitaxel + gemcitabine in 28-day cycles at the discretion of the Investigator without a maximum duration until unacceptable toxicity or PD.
- Conditions
- Pancreatic Neoplasm
- Being tested
- Antroquinonol
- Keywords
- Antroquinonol, Hocena, metastatic pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntroquinonolDrug
Also called Hocena
SOC will via intravenous (IV) infusion on Days 1, 8, and 15. q8w for the first 48 weeks relative to first antroquinonol administration and q12w thereafter, until unacceptable toxicity or progressive disease.
AntroquinonolDrug
Also called Hocena
SOC will via intravenous (IV) infusion on Days 1, 8, and 15. q8w for the first 48 weeks relative to first antroquinonol administration and q12w thereafter, until unacceptable toxicity or progressive disease.
AntroquinonolDrug
Also called Hocena
SOC will via intravenous (IV) infusion on Days 1, 8, and 15. q8w for the first 48 weeks relative to first antroquinonol administration and q12w thereafter, up to and including 24 cycles or until unacceptable toxicity or progressive disease.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 200mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m^2 + gemcitabine 1,000 mg/m^2). Receives: Drug: Antroquinonol |
| Cohort 2 | Experimental | 300mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m^2 + gemcitabine 1,000 mg/m^2). Receives: Drug: Antroquinonol |
| Expansion Cohort | Experimental | 300mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m^2 + gemcitabine 1,000 mg/m^2). Receives: Drug: Antroquinonol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities (MTD)
For phase I: The MTD is the dose at which <33% of patients experience a dose limiting toxicity (DLT) within the first 28-day cycle of antroquinonol and nab-paclitaxel + gemcitabine combined treatment.
Measured: dose escalation: q8w for the first 48 weeks relative to first antroquinonol administration and q12w thereafter, until unacceptable toxicity or progressive disease. The DLT evaluation period will be the first 28-day treatment cycle.
Progression-free Survival (PFS)
For phase II: Anti-tumor activity was assessed through evaluation of the median progression-free survival (PFS) using Investigator assessments according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: From first dose of study drug to the start of disease progression or patient death, whichever occurred first
Secondary outcomes (1)
Overall Survival (OS)
For phase II: OS (months) = (1 + date of OS event or censor - date of first dose) / (365.25 / 12).
Measured: Through out whole study from first dose of study drug to patient death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start1 Dec 2017
- Primary completion30 Dec 2023
- Study completion2 Jan 2024
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 Pancreatic NeoplasmStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Phase I Run-in DDI and dose escalation: Six patients will be enrolled in the run-in DDI cohort of the dose-escalation part of the study (ie, Cohort 1) and 3 to 6 patients may be enrolled in Cohort 2. The total number of patients to be entered in the dose-escalation part of this study will depend on the emergence of DLTs at each dose level, but will be up to 12 if no replacement occurs at the 2 predefined dose levels. Phase II Cohort expansion: Up to an additional 40 patients may be enrolled at the MTD or MFD/RD. A power calculation was not employed to determine the sample size of the study, as this is aproof of concept study with a preliminary assessment of anti-tumor activity of antroquinonol in combination with nab-paclitaxel + gemcitabine in metastatic pancreatic cancer patients.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Golden Biotechnology Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310632
- Sponsor's protocol ID
- GHPanc-1-001
- Status last verified
- Jun 2026
- First submitted
- 1 Oct 2017
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Determine the MTD and to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03310632
- Acronym / sponsor ID
- GHPanc-1-001
- Conditions
- Pancreatic Neoplasm
- Keywords
- Antroquinonol, Hocena, metastatic pancreatic cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Golden Biotechnology CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Antroquinonol is proposed for the treatment of neoplasms. The proposed clinical trial is a Phase I/II study designed to evaluate antroquinonol in combination with nab-paclitaxel and gemcitabine in first line treatment naïve subjects with Stage IV metastatic pancreatic carcinoma. The first part of study will focus on the treatment of pancreatic cancer with 200 mg TID and 300 mg TID, clinical treatment duration of 4 weeks, to determine the MTD or MFD (based on PK and capsules strength) of antroquinonol in combination with a standard dose regimen of nab-paclitaxel and gemcitabine. The extended Phase II will focus on the efficacy of antroquinonol with SOC. Safety and pharmacokinetic profiles will be studied in the proposed clinical trial.
Detailed description
Golden Biotech are planning a Phase I/II study to determine the maximum tolerable dose (MTD) and to evaluate safety/tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of antroquinonol in combination with nab-paclitaxel-gemcitabine in first line metastatic pancreatic cancer.
Phase I
Run-in DDI and dose escalation:
The dose escalation part of the study will be conducted to characterize the safety of antroquinonol in combination with the standard of care (SOC) (nab-paclitaxel + gemcitabine) and to identify the MTD of antroquinonol in patients with metastatic pancreatic cancer. The MTD is the dose level at which <33% (2/6) of patients experience a DLT. Within the dose escalation part of the study, a total of 6 patients will be enrolled in a run-in DDI portion to assess the effect of antroquinonol (a cytochrome P450 [CYP]3A4/CYP2C8 inhibitor) on the PK of paclitaxel (a CYP3A4/CYP2C8 substrate). Patients within this cohort (Cohort 1) will receive treatment as follows:
- Cycle 0 (28-day cycle): nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 (as per SOC) via intravenous (IV) infusion on Days 1, 8, and 15.
- Cycle 1 (28-day cycle): antroquinonol 200 mg administered TID on Days 1 through 28 and nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 via IV infusion on Days 1, 8, and 15.
Intense PK sampling to assess the PK of paclitaxel will be conducted in Cycles 0 and 1. The primary PK endpoints will include Cmax, AUC0-t, and AUCinf. Available bioanalytical data will be assessed in an ongoing manner to assess the effect of antroquinonol on the systemic exposure (Cmax and AUCs) of paclitaxel. Data will be reviewed by the Safety Monitoring Committee (SMC) prior to enrollment of additional patients into the dose-escalation part of the study.
For Cohort 1, the occurrence of DLTs will be assessed from Day 1 to Day 28 of Cycle 1. If ≤1 patient experiences a DLT, dosing in the dose escalation part will proceed. If ≥2 patients experience a DLT, dosing in the dose escalation part of the study will be discontinued. If ≤1 patient in Cohort 1 experiences a DLT then dosing in Cohort 2 of the dose escalation part will proceed as follows: - All Cycles: antroquinonol 300 mg administered TID on Days 1 through 28 and nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 via IV infusion on Days 1, 8, and 15 (ie, 1 cycle = weekly for 3 weeks, then 1 week off) .
Three patients will be enrolled initially into Cohort 2, these patients will be assessed for DLTs within the first 28-day dosing cycle. This cohort will be expanded to 6 total patients if 1 DLT is observed in the first 3 patients within Cohort 2. If ≤1 DLT is observed at the 300 mg dose then the 300 mg dose will be considered the MFD. If >1 DLT is observed at the 300 mg group then 200 mg will be considered the MTD and/or the SMC will review the available data and determine the MTD/recommended dose (RD).
Patients enrolled into the dose escalation part of the study (Cohorts 1 and 2) will continue to receive treatment with antroquinonol (200 or 300 mg, respectively) in combination with nab-paclitaxel + gemcitabine in 28-day cycles at the discretion of the Investigator without a maximum duration until unacceptable toxicity or progressive disease (PD).
The total number of patients to be entered in the dose escalation part of the study will depend on the emergence of DLTs at each dose level and the total number of dose levels investigated. Up to 12 patients are planned to be treated in the dose-escalation part if no patient needs to be replaced for DLT and safety evaluation.
Phase II
Cohort expansion:
During the cohort expansion part of the study, up to an additional 40 patients will be enrolled at the MTD or MFD/RD. The dose level in the cohort expansion phase will not exceed the MTD, or highest safe dose tested in the dose-escalation phase if MTD is not reached. Patients in the cohort expansion will receive treatment as follows:
- All Cycles: antroquinonol at the MTD or MFD/RD administered TID on Days 1 through 28 and nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 via IV infusion on Days 1, 8, and 15 (ie, 1 cycle = weekly for 3 weeks, then 1 week off) .
Patients enrolled into the cohort expansion part of the study will continue to receive treatment with antroquinonol at the MTD or MFD/RD in combination with nab-paclitaxel + gemcitabine in 28-day cycles at the discretion of the Investigator without a maximum duration until unacceptable toxicity or PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase I Run-in DDI and dose escalation: Six patients will be enrolled in the run-in DDI cohort of the dose-escalation part of the study (ie, Cohort 1) and 3 to 6 patients may be enrolled in Cohort 2. The total number of patients to be entered in the dose-escalation part of this study will depend on the emergence of DLTs at each dose level, but will be up to 12 if no replacement occurs at the 2 predefined dose levels. Phase II Cohort expansion: Up to an additional 40 patients may be enrolled at the MTD or MFD/RD. A power calculation was not employed to determine the sample size of the study, as this is aproof of concept study with a preliminary assessment of anti-tumor activity of antroquinonol in combination with nab-paclitaxel + gemcitabine in metastatic pancreatic cancer patients.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Antroquinonol200mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m^2 + gemcitabine 1,000 mg/m^2). |
| Cohort 2 | Experimental | Drug: Antroquinonol300mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m^2 + gemcitabine 1,000 mg/m^2). |
| Expansion Cohort | Experimental | Drug: Antroquinonol300mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m^2 + gemcitabine 1,000 mg/m^2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Male and female patients ≥18 years of age.
- Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas, measurable according to the RECIST 1.1.
- Diagnosed with metastatic disease within 6 weeks before enrollment.
- Treatment-naïve patients with metastatic pancreatic adenocarcinoma who have received no previous systemic therapy (except adjuvant or neoadjuvant therapy if progression occurred >6 months from last treatment or surgery, respectively, and no prior nab-paclitaxel).
- Adequate hematologic, hepatic, and renal function, including:
Key exclusion criteria (12 listed)
- Islet-cell neoplasms or locally advanced disease.
- Chemo-, hormone-, or immunotherapy or investigational drug at Screening or prior to enrollment.
- Treatment with any drug(s) known to be a strong inhibitor or inducer of CYP2C19,CYP3A4, CYP2C8, and CYP2E1 within 14 days of the date of first administration of study drug and during study treatment.
- Other malignancies diagnosed within the past 5 years (other than curatively treated cervical cancer in situ, nonmelanoma skin cancer, superficial bladder tumors Ta [noninvasive tumor] and TIS [carcinoma in situ], or nonmetastatic prostate cancer Stage 1 to 2, which has been previously treated with surgery or radiation therapy, and serum prostate-specific antigen is within normal limits [test performed within the past 12 months prior to the date of first administration of study drug]).
- Patients with any serious active infection (ie, requiring an IV antibiotic, antifungal, or antiviral agent).
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: HocenaSOC will via intravenous (IV) infusion on Days 1, 8, and 15. q8w for the first 48 weeks relative to first antroquinonol administration and q12w thereafter, until unacceptable toxicity or progressive disease. | Drug | Cohort 1 |
| AntroquinonolAlso: HocenaSOC will via intravenous (IV) infusion on Days 1, 8, and 15. q8w for the first 48 weeks relative to first antroquinonol administration and q12w thereafter, until unacceptable toxicity or progressive disease. | Drug | Cohort 2 |
| AntroquinonolAlso: HocenaSOC will via intravenous (IV) infusion on Days 1, 8, and 15. q8w for the first 48 weeks relative to first antroquinonol administration and q12w thereafter, up to and including 24 cycles or until unacceptable toxicity or progressive disease. | Drug | Expansion Cohort |
Primary outcome
Number of Participants With Dose Limiting Toxicities (MTD)
Time frame: dose escalation: q8w for the first 48 weeks relative to first antroquinonol administration and q12w thereafter, until unacceptable toxicity or progressive disease. The DLT evaluation period will be the first 28-day treatment cycle.
For phase I: The MTD is the dose at which <33% of patients experience a dose limiting toxicity (DLT) within the first 28-day cycle of antroquinonol and nab-paclitaxel + gemcitabine combined treatment.
Progression-free Survival (PFS)
Time frame: From first dose of study drug to the start of disease progression or patient death, whichever occurred first
For phase II: Anti-tumor activity was assessed through evaluation of the median progression-free survival (PFS) using Investigator assessments according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
1 secondary outcome
Overall Survival (OS)
Time frame: Through out whole study from first dose of study drug to patient death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Antroquinonol in people with Pancreatic Neoplasm, run by Golden Biotechnology Corporation at 11 sites in 3 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 22 inclusion and 12 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 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, South Korea, 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 2 Jul 2026). 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?
Number of Participants With Dose Limiting Toxicities (MTD) (time frame: dose escalation: q8w for the first 48 weeks relative to first antroquinonol administration and q12w thereafter, until unacceptable toxicity or progressive disease. The DLT evaluation period will be the first 28-day treatment cycle.). The study lists 2 primary outcomes in all. 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 2 Jul 2026.