NCT06017323

Proglumide With Gemcitabine and Nab-Paclitaxel in PatientsWith Metastatic Pancreatic Ductal Adenocarcinoma

Phase I Study of Proglumide With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic DuctalAdenocarcinoma

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I open labelled study to treat patients with metastatic pancreatic cancer with combination therapy using standard of care first line therapy with gemcitabine and nab-paclitaxel given days 1, 8, and 15 every 28 days, and proglumide. This is a phase 1 study with 3+3 design, enrolling3-12 patients over 2 planned dose levels of proglumide(maximum 6 patients per dose level). Proglumide will be tested at the daily dose of 1200 mg orally (PO) given as 400mg three times daily (TID) (dose level 1) or 1600 mg orally(PO) given as 800 mg twice a day (BID) (dose level 2). All cycles are 28 days. Patients will be monitored for safety and toxicity by laboratory blood testing and physical examinations.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	1000mg/m2 IV given days 1, 8, and 15every 28 days (1 cycle)
DRUG	Nab paclitaxel	125 mg/m2 given days 1, 8, and 15every 28 days (1 cycle)
DRUG	Proglumide Dose level 1	Daily dose of 1200 mg orally given as400 mg orally (PO), three times a day(TID) (dose level 1)
DRUG	Proglumide Dose level 2	Daily dose of 1600 mg orally given as800 mg orally (PO) twice a day (BID)(dose level 2).

Timeline

• Start date: 2023-10-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2023-08-30
• Last updated: 2023-10-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study