Study on Antroquinonol with Standard Treatment for First-Time Metastatic Pancreatic Cancer

Sponsor: Golden Biotechnology Corporation

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03310632

Provider View

This clinical trial is testing a new drug, Antroquinonol, combined with standard chemotherapy drugs nab-paclitaxel and gemcitabine, to treat patients with advanced pancreatic cancer who have not received prior treatment. The study aims to find the safest dose and evaluate the effectiveness of this combination.

Patient Parameters

Program Overview

The study is designed to test if Antroquinonol, when used with standard chemotherapy drugs nab-paclitaxel and gemcitabine, can be a safe and effective treatment for patients with advanced pancreatic cancer who have not been treated before. The trial will first determine the safest dose of Antroquinonol and then assess how well it works in combination with the other drugs.

Description

Golden Biotech is conducting a study to find the best dose and evaluate the safety and effectiveness of Antroquinonol combined with nab-paclitaxel and gemcitabine for treating advanced pancreatic cancer.

Phase I

  • The first part of the study will test different doses of Antroquinonol to find the safest amount that can be given with standard chemotherapy. This involves giving patients Antroquinonol along with nab-paclitaxel and gemcitabine and monitoring for any side effects.
  • Patients will receive treatment in 28-day cycles, with Antroquinonol taken three times a day and chemotherapy given on specific days.
  • The study will start with a small group of patients to see how they respond and adjust the dose if needed.

Phase II

  • Once the safest dose is found, more patients will be treated to see how well the combination works in shrinking tumors and improving patient outcomes.
  • Patients will continue to receive the treatment as long as it is effective and does not cause unacceptable side effects.

The study will help determine if this new combination can be a better option for patients with advanced pancreatic cancer.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Diagnosed with advanced pancreatic cancer that has spread and can be measured by scans.
  • Diagnosed with metastatic cancer within 6 weeks before joining the study.
  • Have not received previous treatment for metastatic pancreatic cancer, except in certain cases where previous treatment was given more than 6 months ago.
  • Have good blood, liver, and kidney function based on specific medical tests.
  • Have a performance status that allows for daily activities with minimal restrictions.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study.
  • Willing to provide written consent to participate in the study.
  • Have a life expectancy of at least 12 weeks.

Exclusion Criteria

  • Have a different type of pancreatic cancer or cancer that has not spread.
  • Have received chemotherapy, hormone therapy, or immunotherapy before joining the study.
  • Are taking certain medications that affect the liver enzymes involved in drug metabolism.
  • Have had another type of cancer within the past 5 years, except for certain non-threatening cancers.
  • Have a serious active infection or known infections like HIV, hepatitis B, or hepatitis C.
  • Have other serious health conditions that could interfere with the study.
  • Have a history of substance or alcohol abuse.
  • Have uncontrolled health issues like heart failure or high blood pressure.
  • Are unable to swallow pills or have digestive issues that affect medication absorption.
  • Are pregnant or breastfeeding, or not using effective birth control if of reproductive potential.
  • Have known allergies to any of the study drugs.

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