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1911GCCC: Galeterone With Gemcitabine for Patients With Metastatic Pancreatic Adenocarcinoma | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

1911GCCC: Galeterone With Gemcitabine for Patients With Metastatic Pancreatic Adenocarcinoma

1911GCCC: Open Label, Phase 2 Trial of Galeterone Combined With Gemcitabine for Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Standard Chemotherapy

NCT04098081•University of Maryland, Baltimore

View on ClinicalTrials.gov

Summary

Assess the effectiveness of galeterone in advanced pancreatic adenocarcinoma

Detailed Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of galeterone, an investigational drug, in pancreatic cancer. The FDA (the U.S. Food and Drug Administration) has not approved galeterone for pancreatic cancer. Galeterone is an androgen receptor inhibitor that showed anti-cancer activity in pancreatic cancer in research lab. In this study, the investigator is interested in evaluating galeterone alone or in combination with chemotherapy in treating pancreatic cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Ability to understand and willingness to sign a written informed consent document
•2. Agree to comply with the study requirements and agrees to come to the clinic/hospital for required study visits
•3. 18 years of age or order
•4. Histologic or cytologic diagnosis of pancreatic adenocarcinoma
•5. Measurable metastatic disease documented by CT/MRI at least 1cm in greatest dimension
•6. Have received 2 lines of prior systemic therapy; those patients must demonstrate continued disease progression (RECIST 1.1) and must not have received chemotherapy for at least 4 weeks prior to trial assignment;
•7. ECOG performance status must be 0-2 (Appendix A).
•8. All participants (male and female) with reproductive potential must practice an effective method of contraception while on this study in order to minimize risks to fetuses.
•9. Men and women of all ethnic groups are eligible for this trial.
•10. Able to swallow up to six pills and retain oral medication
+21 more criteria

Exclusion Criteria

•1. 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.
•2. Prior anti-cancer therapy:
•* Prior treatment with galeterone, or anti-androgens.
•* Prior radiation therapy within 4 weeks (if single fraction of radiotherapy within 2 weeks).
•3. Concurrent use of other anti-cancer agents.
•4. Major surgery within 4 weeks prior to randomization.
•5. The following medical conditions:
•* New York Heart Association Class III or IV congestive heart failure.
•* Myocardial infarction/unstable angina (within the 6 months prior to randomization).
•* History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia).
+18 more criteria

Locations (1)

University of Maryland Medical Center

Baltimore, Maryland, United States

Key Dates

Start Date

December 12, 2019

Primary Completion Date

February 17, 2027

Completion Date

December 31, 2027

Last Updated

July 1, 2025

Enrollment

ACTUAL participants

Conditions

Advanced Pancreatic Cancer

Interventions

galeterone

DRUG

Gemcitabine

DRUG

Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)

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Locally Advanced Pancreatic Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

1911GCCC: Galeterone With Gemcitabine for Patients With Metastatic Pancreatic Adenocarcinoma

Inclusion Criteria

Exclusion Criteria

Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)

A Study of GC101 TIL in Advanced Hepatobiliary-Pancreatic Cancers (10hospital)

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