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Antiandrogen
Galeterone +/− Gemcitabine for Pancreatic Cancer
Phase 2
Recruiting
Led By Yixing Jiang, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status must be 0-2 (Appendix A)
Histologic or cytologic diagnosis of pancreatic adenocarcinoma
Must not have
Uncontrolled hypertension (defined as systolic blood pressure > 170 mmHg or diastolic blood pressure of > 105 mmHg measured on at least two occasions, two weeks apart) despite acceptable anti-hypertension therapy
Participation in another clinical trial involving experimental therapy for pancreatic adenocarcinoma within 4 weeks prior to enrollment or simultaneous participation in a study involving investigational treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of death from any cause, assessed up to 100 months
Awards & highlights
Summary
This trial will test whether galeterone can effectively treat advanced pancreatic adenocarcinoma.
Who is the study for?
This trial is for adults over 18 with advanced pancreatic adenocarcinoma who have tried at least two other treatments without success. They must be able to take oral medication, have a life expectancy of more than 12 weeks, and agree to use effective contraception. People with controlled brain metastasis may join, but not those with HIV, recent major surgery or radiation therapy, certain heart conditions, uncontrolled blood pressure issues, or active severe infections.
What is being tested?
The study tests the effectiveness of galeterone alone or combined with gemcitabine in treating metastatic pancreatic cancer. Participants will receive these medications to see if they help control the disease better than previous therapies they've had.
What are the potential side effects?
Potential side effects include allergic reactions to treatment components and possible interactions that could affect liver function or lead to seizures. The exact side effects are not listed but would typically relate to the drugs' impact on organ functions and potential for causing blood count changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of the day.
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I have been diagnosed with pancreatic cancer.
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My blood tests show normal white blood cells, platelets, and hemoglobin levels.
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My liver and kidney functions are within normal ranges.
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I've had 2 treatments for my cancer, it's still growing, and I haven't had chemo in the last 4 weeks.
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I am 18 years old or older.
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I can swallow and keep down up to six pills.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My high blood pressure is not controlled despite treatment.
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I have not been in a pancreatic cancer study with experimental therapy in the last 4 weeks.
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I do not have serious infections or uncontrolled illnesses.
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I am of childbearing age and have a negative pregnancy test.
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I am not using any other cancer treatments.
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I have a history of serious irregular heartbeats.
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I have a history of serious heart rhythm problems but don't have a pacemaker.
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I have a disease affecting my brain or spine.
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I am HIV positive.
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I have a history of seizures or take medication that could increase my risk of seizures.
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I have previously been treated with galeterone or anti-androgens.
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I have not had major surgery in the last 4 weeks.
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I have had adrenal insufficiency or hyperaldosteronism.
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I have severe heart failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until the date of death from any cause, assessed up to 100 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of death from any cause, assessed up to 100 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
response rate
Secondary study objectives
overall survival
progression-free survival
Trial Design
2Treatment groups
Experimental Treatment
Group I: galeterone+gemcitabineExperimental Treatment2 Interventions
daily dose galeterone and weekly dose of gemcitabine
Group II: galeteroneExperimental Treatment1 Intervention
galeterone orally once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~1920
galeterone
2016
Completed Phase 1
~10
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
708 Previous Clinical Trials
379,082 Total Patients Enrolled
Yixing Jiang, MDPrincipal InvestigatorUniversity of Maryland, Baltimore
Aaron Ciner, MDPrincipal InvestigatorUniversity of Maryland, Baltimore
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: galeterone+gemcitabine
- Group 2: galeterone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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