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

NCT06017323 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-10-25

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Georgetown University

    lead OTHER

Principal Investigators

  • Benjamin WE, MD · Georgetown University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT06017323 on ClinicalTrials.gov