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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
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

Study 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.Check my eligibility
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.See study design
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 below
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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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I have a few small brain tumors under control and can sign a consent form.
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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 eligible for this trial regardless of my gender or ethnicity.
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I am 18 years old or older.
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I am using effective birth control during this study.
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I agree to follow the study rules and attend all required visits.
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I can swallow and keep down up to six pills.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of death from any cause, assessed up to 100 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
response rate
Secondary outcome measures
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
galeterone
2016
Completed Phase 1
~10
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
685 Previous Clinical Trials
372,988 Total Patients Enrolled
Yixing Jiang, MDPrincipal InvestigatorUniversity of Maryland, Baltimore
Aaron Ciner, MDPrincipal InvestigatorUniversity of Maryland, Baltimore

Media Library

Galeterone (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT04098081 — Phase 2
Pancreatic Cancer Research Study Groups: galeterone, galeterone+gemcitabine
Pancreatic Cancer Clinical Trial 2023: Galeterone Highlights & Side Effects. Trial Name: NCT04098081 — Phase 2
Galeterone (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04098081 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
~17 spots leftby Dec 2025