NCT04098081

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

Active, enrolled Phase 2 Last updated 1 July 2025

What this trial tests

Phase 2 trial testing galeterone in Advanced Pancreatic Cancer in 15 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

12 December 2019

Primary endpoint
17 February 2027

31 December 2027

Quick facts

Lead sponsor	University of Maryland, Baltimore
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	12 December 2019
Primary completion	17 February 2027
Estimated completion	31 December 2027
Sites	1 location across United States

Drugs / interventions tested

• galeterone — full drug profile →
• Gemcitabine (gemcitabine) — full drug profile →

Conditions studied

• Advanced Pancreatic Cancer — all drugs for Advanced Pancreatic Cancer →

Sponsor

University of Maryland, Baltimore

Who can join

18 and older, any sex, with Advanced Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Assess the effectiveness of galeterone in advanced pancreatic adenocarcinoma

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Comprehensive Account on Recent Progress in Pharmacological Activities of Benzimidazole Derivatives.
   Brishty SR, Hossain MJ, Khandaker MU, Faruque MRI, et al · · 2021 · cited 56× · PMID 34803707 · DOI 10.3389/fphar.2021.762807
2. An Overview of Next-Generation Androgen Receptor-Targeted Therapeutics in Development for the Treatment of Prostate Cancer.
   Mohler ML, Sikdar A, Ponnusamy S, Hwang DJ, et al · · 2021 · cited 41× · PMID 33672769 · DOI 10.3390/ijms22042124
3. Deeping in the Role of the MAP-Kinases Interacting Kinases (MNKs) in Cancer.
   Pinto-Díez C, Ferreras-Martín R, Carrión-Marchante R, González VM, et al · · 2020 · cited 41× · PMID 32340135 · DOI 10.3390/ijms21082967
4. Are targeted therapies or immunotherapies effective in metastatic pancreatic adenocarcinoma?
   Rémond MS, Pellat A, Brezault C, Dhooge M, et al · · 2022 · cited 22× · PMID 36399952 · DOI 10.1016/j.esmoop.2022.100638
5. Translational alterations in pancreatic cancer: a central role for the integrated stress response.
   Shin S, Solorzano J, Liauzun M, Pyronnet S, et al · · 2022 · cited 12× · PMID 36325577 · DOI 10.1093/narcan/zcac031
6. Benzimidazole(s): synthons, bioactive lead structures, total synthesis, and the profiling of major bioactive categories.
   Aroua LM, Alminderej FM, Almuhaylan HR, Alosaimi AH, et al · · 2025 · cited 11× · PMID 40161353 · DOI 10.1039/d4ra08864f
7. Salinization Dramatically Enhance the Anti-Prostate Cancer Efficacies of AR/AR-V7 and Mnk1/2 Molecular Glue Degraders, Galeterone and VNPP433-3β Which Outperform Docetaxel and Enzalutamide in CRPC CWR22Rv1 Xenograft Mouse Model.
   Thankan RS, Thomas E, Purushottamachar P, Weber DJ, et al · · 2023 · cited 8× · PMID 37392559 · DOI 10.1016/j.bioorg.2023.106700
8. Revisiting the role of steroidal therapeutics in the 21st century: an update on FDA approved steroidal drugs (2000-2024).
   Singh R, Bansal R. · · 2025 · cited 7× · PMID 40352672 · DOI 10.1039/d5md00027k