Status:
ACTIVE_NOT_RECRUITING
Determine Function of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic Cancer
Lead Sponsor:
Golden Biotechnology Corporation
Collaborating Sponsors:
Covance
Conditions:
Pancreatic Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 fir...
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 antroqu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03310632
Start Date
December 1 2017
End Date
December 31 2024
Last Update
September 25 2024
Active Locations (9)
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1
Florida Hospital Tampa
Tampa, Florida, United States, 33613
2
CTCA Southeastern Regional Medical Center
Newnan, Georgia, United States, 30265
3
Henry Ford Health System
Detroit, Michigan, United States, 48202
4
Cancer Treatment Centers of America - Eastern Regional Medical Center
Philadelphia, Pennsylvania, United States, 19124