Determine Function of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic Cancer

Korábbi kezelés

• 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.

Más betegség

• Islet-cell neoplasms or locally advanced disease.
• 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.
• 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.
• Any known hypersensitivity to any component of nab-paclitaxel, gemcitabine, or antroquinonol.

Laborértékek

• 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 \[test performed within the past 12 months prior to the date of first administration of study drug\]).

Egyéb

• Known or suspected substance abuse or alcohol abuse.
• Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not employing an effective method of contraception.

• 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
  • 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.