MedTrace Logo

Proglumide and Chemotherapy for Metastatic Pancreatic Cancer

NCT05827055 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-23

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Georgetown University

    lead OTHER

Principal Investigators

  • Benjamin Weinberg, MD · Georgetown University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05827055 on ClinicalTrials.gov