NCT05827055

Proglumide and Chemotherapy for Metastatic Pancreatic Cancer

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, 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

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

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	1000mg/m2 IV given days 1, 8, and 15 every 28 days (1 cycle)
DRUG	Nab paclitaxel	125 mg/m2 given days 1, 8, and 15 every 28 days (1 cycle)
DRUG	Proglumide	Daily dose of 1200 mg orally given as 400 mg orally (PO), three times a day (TID) in vegan capsules
DRUG	Placebo	Placebo given in vegan. capsules orally three times a day

Timeline

• Start date: 2024-01-31
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2023-04-24
• Last updated: 2025-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study