Determine Function of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic C… (NCT03310632) | Clinical Trial Compass
CompletedPhase 1/2
Determine Function of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic Cancer
United States, South Korea, Taiwan55 participantsStarted 2017-12-01
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. ECOG performance status of 0 or 1.
. For women of childbearing potential, a negative serum pregnancy test result at Screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Dose Limiting Toxicities (MTD)
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.
2
Progression-free Survival (PFS)
Timeframe: From first dose of study drug to the start of disease progression or patient death, whichever occurred first
. 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:
Exclusion criteria
. 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.
. 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.