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Anti-metabolites

Dose Level 1:Proglumide TID with Gemcitabine and Nab-Paclitaxel for Pancreatic Cancer (ProglumidePanc Trial)

Phase 1

Waitlist Available

Led By Benjamin WE, MD

Research Sponsored by Georgetown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

ProglumidePanc Trial Summary

This trial is testing a new combo treatment for metastatic pancreatic cancer using standard care + proglumide. 3-12 patients will be monitored for safety and toxicity.

Eligible Conditions

Pancreatic Cancer

ProglumidePanc Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proglumide Recommended Phase II dose and schedule (RP2D)

Secondary outcome measures

Change in tumor marker (CA19-9)

Objective response rate by RECIST v. 1.1

Overall survival (OS)

+1 more

ProglumidePanc Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Level 2:Proglumide BID with Gemcitabine and Nab-PaclitaxelExperimental Treatment3 Interventions

Proglumide given two times a day with gemcitabine and nab-paclitaxel

Group II: Dose Level 1:Proglumide TID with Gemcitabine and Nab-PaclitaxelExperimental Treatment3 Interventions

Proglumide given three times a day with gemcitabine and nab-paclitaxel

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~2070

Nab paclitaxel

2014

Completed Phase 2

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor

343 Previous Clinical Trials

136,502 Total Patients Enrolled

Benjamin WE, MDPrincipal InvestigatorGeorgetown University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks are associated with the administration of Proglumide TID in conjunction with Gemcitabine and Nab-Paclitaxel at Dose Level 1?

"The safety of Dose Level 1: Proglumide TID with Gemcitabine and Nab-Paclitaxel is estimated to be a 1 on the scale of one to three due to this being a Phase 1 trial, which has limited evidence for both safety and efficacy."

Answered by AI

Are enrollees being accepted for this clinical trial currently?

"The trial is not actively recruiting, as verified on clinicaltrials.gov. Initially posted in October of 2023 and last updated September 15th the same year, this research study isn't currently searching for participants; however there are 610 other studies that are presently enrolling volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Proglumide With Gemcitabine and Nab-Paclitaxel in PatientsWith Metastatic Pancreatic Ductal Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06017323.