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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 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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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:

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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

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

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

0 / 21Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

705 Previous Clinical Trials

378,402 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+gemcitabine, galeterone

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

~12 spots leftby Dec 2025

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