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

NCT04098081 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 1911GCCC
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Assess the effectiveness of galeterone in advanced pancreatic adenocarcinoma

Conditions

Advanced Pancreatic Cancer

Keywords

pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• response rate

  number of patients whose disease shrink during treatment

  8 weeks post treatment

Secondary Outcomes (2)

• progression-free survival

  From date of randomization until the date of first documented progression, assessed up to 100 months

• overall survival

  From date of randomization until the date of death from any cause, assessed up to 100 months

Study Arms (2)

galeterone

EXPERIMENTAL

galeterone orally once daily

Drug: galeterone

galeterone+gemcitabine

EXPERIMENTAL

daily dose galeterone and weekly dose of gemcitabine

Drug: galeterone; Drug: Gemcitabine

Interventions

galeterone DRUG

Therapeutic

galeterone; galeterone+gemcitabine

Gemcitabine DRUG

Therapeutic

galeterone+gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and willingness to sign a written informed consent document
• Agree to comply with the study requirements and agrees to come to the clinic/hospital for required study visits
• years of age or order
• Histologic or cytologic diagnosis of pancreatic adenocarcinoma
• Measurable metastatic disease documented by CT/MRI at least 1cm in greatest dimension
• 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;
• ECOG performance status must be 0-2 (Appendix A).
• 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.
• Men and women of all ethnic groups are eligible for this trial.
• Able to swallow up to six pills and retain oral medication
• Expected life expectancy of more than 12 weeks.
• Patient has adequate bone marrow function as demonstrated by the following blood
• counts at Baseline (obtained ≤14 days prior to randomization):
• Absolute neutrophil count (ANC) ≥1.5 × 109/L;
• Platelet count ≥100,000/mm3 (100 × 109/L);

You may not qualify if:

• 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.
• 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).
• Concurrent use of other anti-cancer agents.
• Major surgery within 4 weeks prior to randomization.
• 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).
• History of long QT syndrome, Mobitz II second or third degree heart block without a permanent pacemaker in place.
• Bradycardia as defined by heart rate of \<50 beats/minute at Screening ECG.
• History of chronic or active Hepatitis B or Hepatitis C or other known chronic liver disease. Patients recovered from hepatitis are not excluded from the study.
• Known human immunodeficiency virus (HIV) infection.
• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (14)

• Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

  PMID: 21561347 BACKGROUND

• Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.

  PMID: 24131140 BACKGROUND

• Kwegyir-Afful AK, Murigi FN, Purushottamachar P, Ramamurthy VP, Martin MS, Njar VCO. Galeterone and its analogs inhibit Mnk-eIF4E axis, synergize with gemcitabine, impede pancreatic cancer cell migration, invasion and proliferation and inhibit tumor growth in mice. Oncotarget. 2016 Dec 24;8(32):52381-52402. doi: 10.18632/oncotarget.14154. eCollection 2017 Aug 8.

  PMID: 28881737 BACKGROUND

• Adesso L, Calabretta S, Barbagallo F, Capurso G, Pilozzi E, Geremia R, Delle Fave G, Sette C. Gemcitabine triggers a pro-survival response in pancreatic cancer cells through activation of the MNK2/eIF4E pathway. Oncogene. 2013 Jun 6;32(23):2848-57. doi: 10.1038/onc.2012.306. Epub 2012 Jul 16.

  PMID: 22797067 BACKGROUND

• Arlt A, Gehrz A, Muerkoster S, Vorndamm J, Kruse ML, Folsch UR, Schafer H. Role of NF-kappaB and Akt/PI3K in the resistance of pancreatic carcinoma cell lines against gemcitabine-induced cell death. Oncogene. 2003 May 22;22(21):3243-51. doi: 10.1038/sj.onc.1206390.

  PMID: 12761494 BACKGROUND

• Kwegyir-Afful AK, Bruno RD, Purushottamachar P, Murigi FN, Njar VC. Galeterone and VNPT55 disrupt Mnk-eIF4E to inhibit prostate cancer cell migration and invasion. FEBS J. 2016 Nov;283(21):3898-3918. doi: 10.1111/febs.13895. Epub 2016 Oct 1.

  PMID: 27618366 BACKGROUND

• Montgomery B, Eisenberger MA, Rettig MB, Chu F, Pili R, Stephenson JJ, Vogelzang NJ, Koletsky AJ, Nordquist LT, Edenfield WJ, Mamlouk K, Ferrante KJ, Taplin ME. Androgen Receptor Modulation Optimized for Response (ARMOR) Phase I and II Studies: Galeterone for the Treatment of Castration-Resistant Prostate Cancer. Clin Cancer Res. 2016 Mar 15;22(6):1356-63. doi: 10.1158/1078-0432.CCR-15-1432. Epub 2015 Nov 2.

  PMID: 26527750 BACKGROUND

• Hosein PJ, de Lima Lopes G Jr, Pastorini VH, Gomez C, Macintyre J, Zayas G, Reis I, Montero AJ, Merchan JR, Rocha Lima CM. A phase II trial of nab-Paclitaxel as second-line therapy in patients with advanced pancreatic cancer. Am J Clin Oncol. 2013 Apr;36(2):151-6. doi: 10.1097/COC.0b013e3182436e8c.

  PMID: 22307213 BACKGROUND

• Palacio S, Hosein PJ, Reis I, Akunyili II, Ernani V, Pollack T, Macintyre J, Restrepo MH, Merchan JR, Rocha Lima CM. The nab-paclitaxel/gemcitabine regimen for patients with refractory advanced pancreatic adenocarcinoma. J Gastrointest Oncol. 2018 Feb;9(1):135-139. doi: 10.21037/jgo.2017.10.12.

  PMID: 29564179 BACKGROUND

• Toschi L, Finocchiaro G, Bartolini S, Gioia V, Cappuzzo F. Role of gemcitabine in cancer therapy. Future Oncol. 2005 Feb;1(1):7-17. doi: 10.1517/14796694.1.1.7.

  PMID: 16555971 BACKGROUND

• Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.

  PMID: 2702835 BACKGROUND

• Ivanova A, Qaqish BF, Schell MJ. Continuous toxicity monitoring in phase II trials in oncology. Biometrics. 2005 Jun;61(2):540-5. doi: 10.1111/j.1541-0420.2005.00311.x.

  PMID: 16011702 BACKGROUND

• Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

  PMID: 19097774 BACKGROUND

• Corrie P, Mayer A, Shaw J, D'Ath S, Blagden S, Blesing C, Price P, Warner N. Phase II study to evaluate combining gemcitabine with flutamide in advanced pancreatic cancer patients. Br J Cancer. 2002 Sep 23;87(7):716-9. doi: 10.1038/sj.bjc.6600523.

  PMID: 12232752 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

3-hydroxy-17-(1H-benzimidazole-1-yl)androsta-5,16-diene; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Aaron Ciner, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open Label, Phase 2 Trial of Galeterone Combined with Gemcitabine for Patients with Metastatic Pancreatic Adenocarcinoma Refractory to Standard Chemotherapy

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: December 12, 2019
• Primary Completion (Estimated): February 17, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)