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Golden Biotech GHPanc-1-001: A phase I/II study to determine the maximum tolerated dose (MTD) and to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of antroquinonol in combination with nab-paclitaxel and gemcitabine in first-line metastatic pancreatic cancer

Description

The proposed clinical trial is designed to evaluate antroquinonol in combination with nab-paclitaxel and gemcitabine as a first-line treatment for naïve subjects with stage IV metastatic pancreatic carcinoma. The first part of study will focus on the treatment of pancreatic cancer with 200 mg three times a day and 300 mg three times a day, clinical treatment duration of four weeks, to determine the maximum dose of antroquinonol in combination with a standard dose regimen of nab-paclitaxel and gemcitabine. The extended phase II part of the study will focus on the efficacy of antroquinonol with standard treatment.

Status

Accepting new patients

Primary Study Objective(s)

The primary objectives of this study's phase I, run-in drug-drug interaction and dose escalation, are:

  • To evaluate the effect of antroquinonol 200 mg on the pharmacokinetics of paclitaxel in patients with metastatic pancreatic cancer
  • To determine the maximum tolerated dose or maximum feasible dose of antroquinonol in combination with nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer

The primary objectives of this study's phase II cohort expansion is:

  • To evaluate the anti-tumor activity of antroquinonol in combination with nab-paclitaxel + gemcitabine in patients with metastatic pancreatic cancer

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Are 18 years or older
  • Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas, measurable according to the RECIST 1.1
  • Diagnosed with metastatic disease within six 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
  • Performance status of 0 or 1
  • Life expectancy of ≥12 weeks as assessed by the investigator

Excluding patients who have:

  • Islet-cell neoplasms or locally advanced disease
  • Had chemotherapy, hormone therapy or immunotherapy or investigational drug at screening or prior to enrollment
  • Been treated 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
  • Been diagnosed with other malignancies within the past five 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 I to II, 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])
  • An 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
Learn more about pancreatic cancer
     

Accepting new patients

 

Learn more at

clinicaltrials.gov

 

Principal Investigator(s)

Arturo Loaiza-Bonilla