Clinical trialPhase 2Active not recruiting
Proglumide and Chemotherapy for Metastatic Pancreatic Cancer
Role of Cholecystokinin Receptor Blockade on the Tumor Microenvironment in Pancreatic Cancer
- Outcome
- Ongoing
- Phase
- Phase 2
- Status
- Active not recruiting
- Study type
- Interventional
- Start
- 31 January 2024
- Expected end
- January 2027
- Enrollment
- 30 participants
- Sites
- 1
- Primary outcomes
- Safety of oral proglumide therapy at 1200mg daily dose with chemotherapy
- Sponsor
- Other
- Results posted
- No
- Last update
- 10 June 2026
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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