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

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ClinicalTrials.gov Identifier: NCT03310632
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : April 25, 2018
Sponsor:
Collaborator:
Covance
Information provided by (Responsible Party):
Golden Biotechnology Corporation

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 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.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasm Drug: Antroquinonol Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

Phase I

Run-in DDI and dose escalation:

Six patients will be enrolled in the run-in DDI cohort of the dose-escalation part of the study (ie, Cohort 1) and 3 to 6 patients may be enrolled in Cohort 2. The total number of patients to be entered in the dose-escalation part of this study will depend on the emergence of DLTs at each dose level, but will be up to 12 if no replacement occurs at the 2 predefined dose levels.

Phase II

Cohort expansion:

Up to an additional 40 patients may be enrolled at the MTD or MFD/RD. A power calculation was not employed to determine the sample size of the study, as this is aproof of concept study with a preliminary assessment of anti-tumor activity of antroquinonol in combination with nab-paclitaxel + gemcitabine in metastatic pancreatic cancer patients.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study to Determine the MTD and to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Antroquinonol in Combination With SOC in First Line Metastatic Pancreatic Cancer
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : August 27, 2020
Estimated Study Completion Date : August 27, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Antroquinonol with SOC

Antroquinonol will first be conducted by dose escalation(200mg TID and 300mgTID) to characterize the safety of antroquinonol in combination with the standard of care (SOC) (nab-paclitaxel + gemcitabine) and to identify the MTD of antroquinonol in patients with metastatic pancreatic cancer.

At the cohort expansion part of the study, up to an additional 40 patients will be enrolled at the MTD or MFD/RD.

Drug: Antroquinonol
Antroquinonol: 100 mg and corn oil 100 mg encapsulated in a gelatin capsule administered orally. Dose will be selected(200mg TID or 300mg TID with SOC) after phase I, then follow up the best dose for 40 Patients for the efficacy.
Other Name: Hocena




Primary Outcome Measures :
  1. MTD [ Time Frame: 4 weeks ]

    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



Secondary Outcome Measures :
  1. tumor assessment in millimeters [ Time Frame: up to 48 weeks ]
    measure tumor size by CT or MRI

  2. Body Surface Area in meter^2 [ Time Frame: up to 48 weeks ]
    measure patient's weight and height and calculated by {[Height (cm) × Adjusted Body Weight] × 1/3,600}^1/2

  3. Maximum Plasma Concentration [ Time Frame: 3 weeks ]
    maximum observed plasma concentration of antroquinonol and paclitaxel

  4. Area Under the Curve [ Time Frame: 3 weeks ]
    Plasma concentrations of antroquinonol and paclitaxel will be measured and PK parameters calculated where applicable.

  5. CA19-9 level in units per milli-liter [ Time Frame: up to 48 weeks ]
    blood will be draw and measured. Other emerging antroquinonol biomarkers may be evaluated.

  6. Eastern Cooperative Oncology Group (ECOG) status [ Time Frame: up to 48 weeks ]
    Medical Doctors judged the patient's performance status



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients ≥18 years of age.
  2. Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas, measurable according to the RECIST 1.1.
  3. Diagnosed with metastatic disease within 6 weeks before enrollment.
  4. 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).
  5. 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.
  6. ECOG performance status of 0 or 1.
  7. For women of childbearing potential, a negative serum pregnancy test result at Screening.
  8. 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:

    1. Established use of oral, injected, or implanted hormonal methods of contraception
    2. Placement of an intrauterine device or intrauterine system
    3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
    4. Male sterilization (with the appropriate postvasectomy documentation of the absence of sperm in the ejaculate)
    5. True abstinence (when this is in line with the preferred and usual lifestyle of the patient).
  9. Patient must be able to provide written informed consent for participation in the study.
  10. Life expectancy ≥12 weeks as assessed by the Investigator.

Exclusion Criteria:

  1. Islet-cell neoplasms or locally advanced disease.
  2. Chemo-, hormone-, or immunotherapy or investigational drug at Screening or prior to enrollment.
  3. 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.
  4. 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]).
  5. Patients with any serious active infection (ie, requiring an IV antibiotic, antifungal, or antiviral agent).
  6. Patients with known human immunodeficiency virus, active hepatitis B, or active hepatitis C.
  7. 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.
  8. Known or suspected substance abuse or alcohol abuse.
  9. 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.
  10. 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.
  11. Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not employing an effective method of contraception.
  12. Any known hypersensitivity to any component of nab-paclitaxel, gemcitabine, or antroquinonol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310632


Locations
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United States, Florida
Florida Hospital Tampa Recruiting
Tampa, Florida, United States, 33613
Contact: Alexander Rosemurgy, MD    813-615-7068    heather.bingaman@ahss.org   
Contact: Heather Bingaman    813-615-7068    heather.bingaman@ahss.org   
United States, Georgia
CTCA Southeastern Regional Medical Center Recruiting
Newnan, Georgia, United States, 30265
Contact: Alexandria Phan, M.D.    770-400-6000    karen.rados@ctca-hope.com   
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Ding Wang, M.D.    313-916-3721    SMINTOF1@HFHS.ORG   
United States, Pennsylvania
Cancer Treatment Centers of America - Eastern Regional Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19124
Contact: Arturo Loaiza-Bonilla, M.D.    215-537-4555    arturo.loaiza-bonilla@ctca-hope.com   
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Contact: Yan-Shen Shan, M.D.    +886 6-2353535    ysshan@mail.ncku.edu.tw   
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Chung-Pin Li, M.D.    +886 2-28712121    cpli@vghtpe.gov.tw   
Sponsors and Collaborators
Golden Biotechnology Corporation
Covance

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Responsible Party: Golden Biotechnology Corporation
ClinicalTrials.gov Identifier: NCT03310632     History of Changes
Other Study ID Numbers: GHPanc-1-001
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Golden Biotechnology Corporation:
Antroquinonol
Hocena
metastatic pancreatic cancer

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Ubiquinone
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs