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Antroquinonol for Metastatic Pancreatic Cancer
Study Summary
This trial is designed to study a new cancer treatment, antroquinonol, in patients with pancreatic cancer that has spread to other parts of the body. The first part of the trial will focus on finding the best dose of the new drug, while the second part will focus on its effectiveness.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 2 trial • 31 Patients • NCT02047344Trial Design
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- My condition involves a tumor in the pancreas.I cannot take pills by mouth or have severe ongoing diarrhea.I haven't taken any strong medication affecting liver enzymes in the last 14 days.I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.I have HIV, active hepatitis B, or active hepatitis C.I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.You have a known or suspected problem with drugs or alcohol.I have not started any new cancer treatments recently.I do not have a serious infection requiring IV treatment.I haven't had any cancer except for certain skin, cervical, bladder, or early prostate cancers in the last 5 years.I am not allergic to nab-paclitaxel, gemcitabine, or antroquinonol.Your blood, liver, and kidney function tests must show that they are working properly. Your hemoglobin, white blood cell count, platelet count, liver enzymes, albumin, and kidney function need to be within certain ranges.My pancreatic cancer is confirmed and measurable.I am fully active or can carry out light work.Women who could become pregnant must have a negative pregnancy test before joining the study.I agree to use two effective birth control methods during and 3 months after the study.I have metastatic pancreatic cancer and haven't received systemic therapy, except possibly adjuvant or neoadjuvant therapy if my cancer progressed more than 6 months after the last treatment or surgery, and I have never had nab-paclitaxel.I am 18 years old or older.I was diagnosed with cancer that has spread within the last 6 weeks.The doctor thinks you will live for at least 12 more weeks.
- Group 1: Antroquinonol with SOC
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What objectives is this clinical trial seeking to accomplish?
"According to the trial sponsor, Covance, primary measurements of efficacy over a 4 week period will focus on tumor assessment in millimeters. Additionally, secondary outcomes such as CA19-9 levels in units/mL and antroquinonol biomarkers may also be observed. Furthermore, this study looks at maximum plasma concentrations of both paclitaxel and antroquinonol as well calculating their respective areas under the curve (AUC) values."
Are there any vacancies available for prospective participants in this research project?
"Unfortunately, the recruitment period for this trial has closed. Initially posted on December 1st 2017 and updated last on August 16th 2022, it is no longer recruiting participants. However, there are presently 578 clinical trials actively seeking people with pancreatic cancer and 2 studies looking to enrol patients using Antroquinonol concurrently."
What other research initiatives have been taken for understanding the efficacy of Antroquinonol?
"First discovered in 2017 at Severance Hospital, antroquinonol has since undergone 6 clinical trials. Presently, 2 active studies are underway and many of these experiments take place in Tampa, Florida."
How many participants is the upper limit for this research initiative?
"Unfortunately, no new participants are being recruited for this medical trial at the moment. The study was first published on December 1st 2017 and has since been updated as recently as August 16th 2022. If you're searching for other trials to join, 578 studies are currently seeking patients with pancreatic cancer while 2 clinical investigations require participants that want to try Antroquinonol."
Would this be considered an innovative clinical trial?
"At present, two active trials are utilizing Antroquinonol to treat patients in five cities and three countries. This drug was initially studied back in 2017 by Covance; the study involved fifty-two participants and successfully went through both Phase 1 & 2 of clinical approval. Subsequent studies have been conducted over the past four years, with a total of six completed thus far."
How wide-reaching is this research initiative?
"At this time, 4 different sites are enrolling patients into the trial. These locations can be found in Tampa, Detroit, Philadelphia and several other municipalities; thus it is advisable to select the nearest medical centre when considering participation to reduce travel requirements."
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