Advanced Pancreatic CancerPhase 2NCT04098081
1911GCCC: Galeterone With Gemcitabine for Patients With Metastatic Pancreatic Adenocarcinoma
A Phase 2 study testing galeterone and Gemcitabine in people with Advanced Pancreatic Cancer, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Assess the effectiveness of galeterone in advanced pancreatic adenocarcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Pancreatic Cancer
- What is being tested?
- galeterone and Gemcitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2019to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 18 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;
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- 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);
- Hemoglobin (Hgb) ≥ 8 g/dL.
- Patient has adequate organ functions at baseline (obtained ≤14 days prior to randomization):
- AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN),
- Total bilirubin ≤ 1.2mg/dl
- Serum creatinine within normal limits or calculated clearance ≥50 mL/min. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg, using the Cockroft-Gault formula). For patients with a Body Mass Index (BMI) >30 kg/m2, adjusted body weight should be used instead.
- Patients with well controlled oligo brain metastasis are eligible 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.
- 18 years of age or order.
- Histologic or cytologic diagnosis of stage IV pancreatic adenocarcinoma.
- Measurable disease per RECIST 1.1 criteria.
- 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 agree to be abstinent or 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.
Who cannot join
- 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.
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- 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.
- Hypotension (defined as systolic blood pressure <90 mmHg).
- History of adrenal insufficiency or hyperaldosteronism.
- Gastrointestinal disorders or gastric bypass surgery, with the exception of pancreatic cancer and its complications, including lap bands that could interfere with the absorption of galeterone.
- Serious active infections requiring systemic treatment or nonmalignant medical illnesses that are uncontrolled.
- History of seizure or any condition or concomitant use of any medication that may predispose to seizure or lower the seizure threshold.
- History of loss of consciousness or transient ischemic attack within 12 months of randomization.
- History of (in the past 5 years) other malignancy, other than curatively treated nonmelanomatous skin cancer and superficial transitional cell carcinoma of the bladder.
- Cranial/spinal epidural disease.
- The patient has known allergy to any of the treatment components.
- Any physical or mental condition or social situation that, in the opinion of the Investigator, may interfere with the patient's ability to comply with the trial procedures, confound the ability to interpret data from the study or places the patient at unacceptable risk if he participates in this study.
- Current alcohol abuse or illicit drug use.
- Since the teratogenic potential of this combination is currently unknown, females who are pregnant or lactating are excluded.
- Females at reproductive age must have a negative urine pregnancy test prior to entry to this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: 1911GCCC: Open Label, Phase 2 Trial of Galeterone Combined With Gemcitabine for Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Standard Chemotherapy
Assess the effectiveness of galeterone in advanced pancreatic adenocarcinoma
Read the 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.
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- galeterone, Gemcitabine
- Keywords
- pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
galeteroneDrug
Therapeutic
GemcitabineDrug
Therapeutic
| Study group | Role | What they receive |
|---|---|---|
| galeterone | Experimental | galeterone orally once daily Receives: Drug: galeterone |
| galeterone+gemcitabine | Experimental | daily dose galeterone and weekly dose of gemcitabine Receives: Drug: galeterone; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
number of patients whose disease shrink during treatment
Measured: 8 weeks post treatment
Secondary outcomes (2)
progression-free survival
time for galeterone to control the disease
Measured: From date of randomization until the date of first documented progression, assessed up to 100 months
overall survival
total life expectancy
Measured: From date of randomization until the date of death from any cause, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start12 Dec 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Open Label, Phase 2 Trial of Galeterone Combined with Gemcitabine for Patients with Metastatic Pancreatic Adenocarcinoma Refractory to Standard Chemotherapy
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron Ciner, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098081
- Sponsor's protocol ID
- 1911GCCC
- Status last verified
- Jun 2026
- First submitted
- 18 Sep 2019
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21561347Von 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.
PubMed 24131140Kwegyir-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.
PubMed 28881737Adesso 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.
PubMed 22797067Arlt 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.
PubMed 12761494Kwegyir-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.
PubMed 27618366Montgomery 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.
PubMed 26527750Hosein 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.
PubMed 22307213Palacio 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.
PubMed 29564179Toschi 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.
PubMed 16555971Simon 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.
PubMed 2702835Ivanova 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.
PubMed 16011702Eisenhauer 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.
PubMed 19097774Corrie 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.
PubMed 12232752
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1911GCCC: Open Label, Phase 2 Trial of Galeterone Combined With Gemcitabine for Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Standard Chemotherapy
- ClinicalTrials.gov ID
- NCT04098081
- Acronym / sponsor ID
- 1911GCCC
- Conditions
- Advanced Pancreatic Cancer
- Keywords
- pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open Label, Phase 2 Trial of Galeterone Combined with Gemcitabine for Patients with Metastatic Pancreatic Adenocarcinoma Refractory to Standard Chemotherapy
| Arm | Type | Receives |
|---|---|---|
| galeterone | Experimental | Drug: galeteronegaleterone orally once daily |
| galeterone+gemcitabine | Experimental | Drug: galeterone, Drug: Gemcitabinedaily dose galeterone and weekly dose of gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- 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
- 18 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
Key exclusion criteria (28 listed)
- 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:
- Concurrent use of other anti-cancer agents.
- Major surgery within 4 weeks prior to randomization.
- The following medical conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| galeteroneTherapeutic | Drug | galeterone, galeterone+gemcitabine |
| GemcitabineTherapeutic | Drug | galeterone+gemcitabine |
Primary outcome
response rate
Time frame: 8 weeks post treatment
number of patients whose disease shrink during treatment
2 secondary outcomes
progression-free survival
Time frame: From date of randomization until the date of first documented progression, assessed up to 100 months
overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 100 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 21561347Conroy 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.
- Background: PubMed 24131140Von 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.
- Background: PubMed 28881737Kwegyir-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.
- Background: PubMed 22797067Adesso 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.
- Background: PubMed 12761494Arlt 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.
- Background: PubMed 27618366Kwegyir-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.
- Background: PubMed 26527750Montgomery 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.
- Background: PubMed 22307213Hosein 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.
- Background: PubMed 29564179Palacio 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.
- Background: PubMed 16555971Toschi 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.
- Background: PubMed 2702835Simon 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.
- Background: PubMed 16011702Ivanova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Ciner, MD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing galeterone and Gemcitabine in people with Advanced Pancreatic Cancer, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: 8 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04098081, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.