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Metastatic Pancreatic CancerPhase 2ProGemNCT05827055

Proglumide and Chemotherapy for Metastatic Pancreatic Cancer

A Phase 2 study testing Gemcitabine, Nab paclitaxel and Proglumide in people with Metastatic Pancreatic Cancer, run by Georgetown University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a Phase 2 study with an open labelled lead-in study to approximately treat 30 patients [6 subjects for Lead-in and 24 for Phase 2] enrolled with metastatic pancreatic cancer with combination therapy using standard of care first line therapy with GEM-NAB-P (GEM 1000mg/m2 IV and NAB-P 125 mg/m2 given days 1, 8… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
Gemcitabine, Nab paclitaxel and Proglumide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
31 Jan 2024to Jan 2027
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

  • Written informed consent and any locally-required authorization (e.g., HIPAA in the USA) obtained from the patient prior to performing any protocol-related procedures, including screening evaluations
  • Age > 18 years at time of study entry.
  • Adequate normal organ and marrow function as defined below:
  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count (ANC) > 1500 per mm3
  • Platelet count ≥100,000 per mm3)
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  • Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN).
  • AST and ALT ≤2.5 x ULN of normal unless liver metastases are present, in which case it must be ≤5x ULN
  • Creatinine clearance (CL) >60 mL/min using the Cockroft-Gault formula.
  • Evidence of post-menopausal status or negative urine or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments, or if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Patients must have measurable disease by RECIST v1.1 and disease amenable to serial biopsy.
  • Subjects may not have received prior therapy with GEM/NAB-P.
  • Patients must have metastatic pancreatic ductal adenocarcinoma with adenocarcinoma as the dominant histology (biopsy-proven, primary tumor biopsy is acceptable for eligibility)
  • No prior systemic treatment contain GEM or NAB-P.
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Who cannot join

  • Subjects with a concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer, or localized prostate cancer following definitive therapy.
  • Subjects with uncontrolled cardiovascular diseases (congestive heart failure, symptoms of coronary artery disease, cardiac arrhythmias) or who have suffered a myocardial infarction in the preceding 6 months.
  • Blood anticoagulation that cannot be safely stopped for biopsy.
  • Subjects with poorly controlled medical conditions including asthma, chronic obstructive pulmonary disease, diabetes, seizure disorders, hepatic or renal failure.
  • Pregnant or nursing women.
  • Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence) prior to study entry, for the duration of study participation, and for 6 months thereafter.
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  • Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
  • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
  • History of allogenic organ transplantation.
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea or inability to digest and absorb pills, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies).
  • Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible.
  • Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Testing for tuberculosis, hepatitis B and C and HIV is not a requirement for screening for the clinical trial.
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational drug. Note: Patients, if enrolled, should not receive live vaccine while receiving IP and up to 30 days after the last dose of IP.
  • Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of proglumide therapy.
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • Patient is unable to swallow pills or has a malabsorption syndrome that would not enable the patient to properly absorb proglumide.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lombardi Comprehensive Cancer Center, Georgetown University

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: Role of Cholecystokinin Receptor Blockade on the Tumor Microenvironment in Pancreatic Cancer

This is a Phase 2 study with an open labelled lead-in study to approximately treat 30 patients [6 subjects for Lead-in and 24 for Phase 2] enrolled with metastatic pancreatic cancer with combination therapy using standard of care first line therapy with GEM-NAB-P (GEM 1000mg/m2 IV and NAB-P 125 mg/m2 given days 1, 8, and 15 every 28 days, and proglumide will be tested at the daily dose of 1200 mg orally given as 400 mg po TID. The lead-in study will determine the safety and tolerability of the 1200 mg daily dose of proglumide with standard of care GEM-NAB-P. If 0 or 1 of a total of 6 patients at 400mg experiences a DLT, then we will proceed to the Phase 2 randomized trial.

Read the detailed description

After the Lead-in study, in the Phase 2 portion, patients will be randomized 1:1 to standard of care chemotherapy using gemcitabine (GEM) and nab-paclitaxel (NAB-P) (GEM 1000 mg/m2 IV and NAB-P 125 mg/m2 given days 1, 8, and 15 every 28 days) plus placebo or proglumide at the recommended phase 2 dose (RP2D) for proglumide determined in the Lead-in study. Patients will be monitored for safety and toxicity by laboratory blood testing, physical examinations, neurological check, and cardiac monitoring in the Lead-in study. Dosing of chemotherapy will be managed following USPI recommendations. If dose-related toxicity occurs with proglumide, the medication will be held until the AE resolves. Proglumide will then be re-administered at the prior lower dose.

A research tumor biopsy will be performed before starting therapy. Every 8 weeks radiographic imaging will be done for assess tumor burden according to Standard of Care (SOC). Blood work for safety analysis will be done at 2 weeks, then every 4 weeks, interim vital signs and history is done every 4 weeks. Radiographic imaging and CA19-9 tumor marker will be done every 8 weeks according to SOC. A repeat tumor biopsy will be done at week 8 only for research purposes to examine the tumor microenvironment. A blood sample for research Biomarkers will be collected before starting therapy and every 8 weeks. Patients will be treated for 24 weeks or until progression is documented, unacceptable toxicities develop, or treatment is no longer required

Being tested
Gemcitabine, Nab paclitaxel, Proglumide, Placebo
Keywords
Proglumide, 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.

  • GemcitabineDrug

    Also called Gemzar

    1000mg/m2 IV given days 1, 8, and 15 every 28 days (1 cycle)

  • Nab paclitaxelDrug

    Also called Abraxane

    125 mg/m2 given days 1, 8, and 15 every 28 days (1 cycle)

  • ProglumideDrug

    Also called Milid

    Daily dose of 1200 mg orally given as 400 mg orally (PO), three times a day (TID) in vegan capsules

  • PlaceboDrug

    Also called Avicel capsules

    Placebo given in vegan. capsules orally three times a day

Study groups in NCT05827055
Study groupRoleWhat they receive
Proglumide TID with Gemcitabine and Nab-PaclitaxelExperimentalProglumide given three times a day with gemcitabine and nab-paclitaxel
Receives: Drug: Gemcitabine; Drug: Nab paclitaxel; Drug: Proglumide
Placebo TID with Gemcitabine and Nab-PaclitaxelExperimentalPlacebo given three times a day with gemcitabine and nab-paclitaxel
Receives: Drug: Gemcitabine; Drug: Nab paclitaxel; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of oral proglumide therapy at 1200mg daily dose with chemotherapy

    The number of abnormal serum chemistry values occurring in those on proglumide compared to those on placebo

    Measured: 18 months

Secondary outcomes (4)

  1. Fibrosis in the pancreatic tumor microenvironment

    The amount of fibrosis measured on the tumor biopsy with histologic staining in subjects on the proglumide arm compared to the measurment of fibrosis (by intergartive density score) to those on placebo

    Measured: 3 years

  2. Overall survival (OS)

    median overall survival will be estimated using Kaplan-Meier curves.

    Measured: 4 years

  3. Progression-free survival

    median progression free survival will be estimated using Kaplan-Meier curves.

    Measured: 4 years

  4. Effects of proglumide on Pain

    compare pain intensity and management in those on proglumide compared to placebo using the McGill Pain Survey.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2023
  2. Study start31 Jan 2024
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

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
Sequential
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05827055
Sponsor's protocol ID
STUDY00006978
Other IDs
01899
Acronym
ProGem
Status last verified
Jun 2026
First submitted
11 Apr 2023
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, Nab paclitaxel and Proglumide in people with Metastatic Pancreatic Cancer, run by Georgetown University 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 16 inclusion and 18 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 10 Jun 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?

Safety of oral proglumide therapy at 1200mg daily dose with chemotherapy (time frame: 18 months). 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 NCT05827055.

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 10 Jun 2026.

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