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Galeterone +/− Gemcitabine for Pancreatic Cancer
Study Summary
This trial will test whether galeterone can effectively treat advanced pancreatic adenocarcinoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I can take care of myself and am up and about more than half of the day.Your heart beats too slowly, less than 50 beats per minute.I have been diagnosed with pancreatic cancer.I have not had a fainting spell or mini-stroke in the last year.You are currently misusing alcohol or using illegal drugs.You have confirmed spread of the disease that can be measured to be at least 1cm in size using a CT or MRI scan.My blood tests show normal white blood cells, platelets, and hemoglobin levels.My high blood pressure is not controlled despite treatment.I don't have GI disorders or surgeries that could affect medication absorption, except for issues related to pancreatic cancer.I have a few small brain tumors under control and can sign a consent form.My liver and kidney functions are within normal ranges.I have not been in a pancreatic cancer study with experimental therapy in the last 4 weeks.I do not have serious infections or uncontrolled illnesses.I am of childbearing age and have a negative pregnancy test.I am not using any other cancer treatments.I have a history of serious irregular heartbeats.I have a history of serious heart rhythm problems but don't have a pacemaker.I've had 2 treatments for my cancer, it's still growing, and I haven't had chemo in the last 4 weeks.I have or had hepatitis or another chronic liver disease but am not currently ill from it.I have a disease affecting my brain or spine.I am eligible for this trial regardless of my gender or ethnicity.I am 18 years old or older.I haven't had any cancer except for skin cancer or superficial bladder cancer in the last 5 years.I am HIV positive.I am using effective birth control during this study.I have not had radiation therapy in the last 4 weeks.I have a history of seizures or take medication that could increase my risk of seizures.I have previously been treated with galeterone or anti-androgens.I have not had a heart attack or unstable chest pain in the last 6 months.I agree to follow the study rules and attend all required visits.I can swallow and keep down up to six pills.I have not had major surgery in the last 4 weeks.I have had adrenal insufficiency or hyperaldosteronism.I have severe heart failure.Your blood pressure is too low, with a systolic reading below 90 mmHg.
- Group 1: galeterone
- Group 2: galeterone+gemcitabine
- 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
Is enrollment open for this experimental research endeavor?
"According to data hosted on clinicaltrials.gov, this investigation is actively recruiting patients and has been since it was initially posted in December 2019 with the last update occurring March 2022."
What is the scope of participants for this particular trial?
"Affirmative. Per information from clinicaltrials.gov, recruitment for this medical study is ongoing; the trial was first posted on December 12th 2019 and updated most recently on March 10th 2022. The goal is to enroll 58 participants at one location."
Has galeterone been the focus of any previous research initiatives?
"Presently, 446 clinical trials assessing the effectiveness of galeterone are taking place. Of these, 134 are in Phase 3 and conducted across 24565 sites with a large concentration located in Woolloongabba, Queensland."
What medical conditions is galeterone typically employed to combat?
"Galeterone is largely prescribed for small cell lung cancer (SCLC), but it has also found success in treating other forms of cancer such as head and neck carcinoma, pancreatic adenocarcinoma locally advanced and cervical cancers."
Could you elucidate the potential risks associated with galeterone?
"Although data related to the efficacy of galeterone is limited, there has been sufficient research conducted that suggests it is safe. Therefore, our team at Power gave this medication a score of 2 out of 3."
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