Trial Outcomes & Findings for Determine Function of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic Cancer (NCT NCT03310632)
NCT ID: NCT03310632
Last Updated: 2026-07-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
55 participants
Primary outcome timeframe
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.
Results posted on
2026-07-02
Participant Flow
participants were recruited between Dec 2017 to Jul 2022 from US, Korea and Taiwan sites.
Participant milestones
| Measure |
Cohort 1
200mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
Cohort 2
300mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
Expansion Cohort
300mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
3
|
40
|
|
Overall Study
COMPLETED
|
12
|
3
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
No differences between the population numbers in the row(s) and the overall numbers
Baseline characteristics by cohort
| Measure |
Cohort 1
n=12 Participants
200mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
Cohort 2
n=3 Participants
300mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
Expansion Cohort
n=40 Participants
300mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65 Years
STANDARD_DEVIATION 11.5 • n=20 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
64 Years
STANDARD_DEVIATION 1.0 • n=20 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
63 Years
STANDARD_DEVIATION 10.6 • n=40 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
64 Years
STANDARD_DEVIATION 10.4 • n=5 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
|
Sex: Female, Male
Female
|
5 Participants
n=20 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
3 Participants
n=20 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
15 Participants
n=40 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
23 Participants
n=5 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
|
Sex: Female, Male
Male
|
7 Participants
n=20 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
0 Participants
n=20 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
25 Participants
n=40 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
32 Participants
n=5 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
|
Race/Ethnicity, Customized
Race · Asian
|
5 Participants
n=20 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
3 Participants
n=20 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
32 Participants
n=40 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
40 Participants
n=5 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=20 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
0 Participants
n=20 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
3 Participants
n=40 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
4 Participants
n=5 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
|
Race/Ethnicity, Customized
Race · White
|
6 Participants
n=20 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
0 Participants
n=20 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
5 Participants
n=40 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
11 Participants
n=5 Participants • No differences between the population numbers in the row(s) and the overall numbers
|
PRIMARY outcome
Timeframe: 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.Population: The DLT Analysis Set only applied to the dose-escalation part of the study (Cohorts 1 and 2). Nine patients of Cohort 1 and all 3 patients of Cohort 2 were included in the DLT Analysis Set. Three patients of Cohort 1 had not completed Cycle 1 or had not received at least 90% or more of all planned total doses of antroquinonol during Cycle 1.
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.
Outcome measures
| Measure |
Cohort 1
n=9 Participants
200mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
Cohort 2
n=3 Participants
300mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
Expansion Cohort
300mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (MTD)
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug to the start of disease progression or patient death, whichever occurred firstFor 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.
Outcome measures
| Measure |
Cohort 1
n=12 Participants
200mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
Cohort 2
n=3 Participants
300mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
Expansion Cohort
n=39 Participants
300mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
5.0431 months
Interval 3.0554 to 8.2793
|
5.8973 months
Interval 3.7125 to 8.0821
|
5.2895 months
Interval 3.7125 to 7.5236
|
SECONDARY outcome
Timeframe: Through out whole study from first dose of study drug to patient deathFor phase II: OS (months) = (1 + date of OS event or censor - date of first dose) / (365.25 / 12).
Outcome measures
| Measure |
Cohort 1
n=12 Participants
200mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
Cohort 2
n=3 Participants
300mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
Expansion Cohort
n=39 Participants
300mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
|---|---|---|---|
|
Overall Survival (OS)
|
12.3860 months
Interval 5.4538 to 36.1396
|
7.4415 months
Interval 6.8008 to 8.0821
|
14.1273 months
Interval 10.0862 to 18.3655
|
Adverse Events
Cohort 1
Serious events: 8 serious events
Other events: 12 other events
Deaths: 8 deaths
Cohort 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Expansion Cohort
Serious events: 18 serious events
Other events: 40 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Cohort 1
n=12 participants at risk
200mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
Cohort 2
n=3 participants at risk
300mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
Expansion Cohort
n=40 participants at risk
300mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
|---|---|---|---|
|
General disorders
Pyrexia
|
16.7%
2/12 • Number of events 2 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
5.0%
2/40 • Number of events 2 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
2.5%
1/40 • Number of events 3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
5.0%
2/40 • Number of events 2 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
2.5%
1/40 • Number of events 3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
2.5%
1/40 • Number of events 3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
5.0%
2/40 • Number of events 2 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
2/12 • Number of events 2 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/40 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Infections and infestations
Septic shock
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
5.0%
2/40 • Number of events 2 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Gastrointestinal disorders
Upper gastrointestinal
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
33.3%
1/3 • Number of events 2 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/40 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Renal and urinary disorders
Acute kidney injury
|
8.3%
1/12 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/40 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
8.3%
1/12 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/40 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
General disorders
Asthenia
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
2.5%
1/40 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Hepatobiliary disorders
Bile duct obstruction
|
8.3%
1/12 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/40 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
2.5%
1/40 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
2.5%
1/40 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
2.5%
1/40 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Nervous system disorders
Coma
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
2.5%
1/40 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Metabolism and nutrition disorders
Dehydration
|
8.3%
1/12 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/40 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
2.5%
1/40 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
8.3%
1/12 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/40 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
2.5%
1/40 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Infections and infestations
Liver abscess
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
2.5%
1/40 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
2.5%
1/40 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
2.5%
1/40 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
2.5%
1/40 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
2.5%
1/40 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
2.5%
1/40 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Infections and infestations
Sepsis
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
2.5%
1/40 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
2.5%
1/40 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
2.5%
1/40 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
33.3%
1/3 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/40 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
Other adverse events
| Measure |
Cohort 1
n=12 participants at risk
200mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
Cohort 2
n=3 participants at risk
300mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
Expansion Cohort
n=40 participants at risk
300mg TID Antroquinonol combination with the standard of care (SOC) (nab-paclitaxel 125 mg/m\^2 + gemcitabine 1,000 mg/m\^2).
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
25.0%
3/12 • Number of events 4 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
15.0%
6/40 • Number of events 7 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
2/12 • Number of events 5 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
10.0%
4/40 • Number of events 5 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Gastrointestinal disorders
Vomiting
|
58.3%
7/12 • Number of events 13 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
100.0%
3/3 • Number of events 4 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
72.5%
29/40 • Number of events 52 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Gastrointestinal disorders
Diarrhoea
|
58.3%
7/12 • Number of events 10 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
66.7%
2/3 • Number of events 4 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
60.0%
24/40 • Number of events 51 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Gastrointestinal disorders
Nausea
|
50.0%
6/12 • Number of events 10 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
33.3%
1/3 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
75.0%
30/40 • Number of events 41 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
33.3%
1/3 • Number of events 2 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
17.5%
7/40 • Number of events 10 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
15.0%
6/40 • Number of events 7 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
50.0%
6/12 • Number of events 23 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
33.3%
1/3 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
35.0%
14/40 • Number of events 38 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Blood and lymphatic system disorders
Anaemia
|
58.3%
7/12 • Number of events 24 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
66.7%
2/3 • Number of events 2 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
17.5%
7/40 • Number of events 12 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Blood and lymphatic system disorders
Leukopenia
|
66.7%
8/12 • Number of events 19 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
15.0%
6/40 • Number of events 8 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
General disorders
Fatigue
|
50.0%
6/12 • Number of events 13 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
66.7%
2/3 • Number of events 2 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
47.5%
19/40 • Number of events 35 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
General disorders
Oedema peripheral
|
58.3%
7/12 • Number of events 9 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
100.0%
3/3 • Number of events 3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
20.0%
8/40 • Number of events 10 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
General disorders
Pyrexia
|
33.3%
4/12 • Number of events 7 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
12.5%
5/40 • Number of events 9 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
General disorders
Asthenia
|
33.3%
4/12 • Number of events 5 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
15.0%
6/40 • Number of events 8 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
General disorders
Chills
|
33.3%
4/12 • Number of events 4 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
7.5%
3/40 • Number of events 3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Investigations
Neutrophil count decreased
|
58.3%
7/12 • Number of events 26 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
50.0%
20/40 • Number of events 49 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
12.5%
5/40 • Number of events 5 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Nervous system disorders
Dizziness
|
25.0%
3/12 • Number of events 3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
66.7%
2/3 • Number of events 2 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
35.0%
14/40 • Number of events 21 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Nervous system disorders
Neuropathy peripheral
|
41.7%
5/12 • Number of events 6 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
33.3%
1/3 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
17.5%
7/40 • Number of events 17 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
1/12 • Number of events 2 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
33.3%
1/3 • Number of events 2 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
12.5%
5/40 • Number of events 7 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Nervous system disorders
Headache
|
25.0%
3/12 • Number of events 3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
0.00%
0/3 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
12.5%
5/40 • Number of events 5 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
41.7%
5/12 • Number of events 7 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
66.7%
2/3 • Number of events 5 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
42.5%
17/40 • Number of events 24 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
2/12 • Number of events 8 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
33.3%
1/3 • Number of events 1 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
17.5%
7/40 • Number of events 11 • Adverse event reporting began from the time of informed consent and ended 3 months after the last dose of study drug, an average of 10 months.
The Adverse Event reporting included all patients who received at least 1 administration of the trial medication (ie, actual total dose of antroquinonol or nab-paclitaxel + gemcitabine \>0).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place