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Anti-metabolites

Proglumide + Chemotherapy for Pancreatic Cancer (ProGem Trial)

Phase 2

Recruiting

Led By Benjamin Weinberg, MD

Research Sponsored by Georgetown University

Eligibility Criteria Checklist

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

Must have

Age > 18 years at time of study entry

Adequate normal organ and marrow function as defined below: Hemoglobin ≥ 9.0 g/dL, Absolute neutrophil count (ANC) > 1500 per mm3, Platelet count ≥100,000 per mm3, Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN), AST and ALT ≤2.5 x ULN of normal unless liver metastases are present, in which case it must be ≤5x ULN, Creatinine clearance (CL) >60 mL/min using the Cockroft-Gault formula

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

ProGem Trial Summary

This trial tests a combination therapy to treat pancreatic cancer. Patients get standard care plus a drug called proglumide at different doses. All patients are monitored to check safety and side effects.

Who is the study for?

Adults over 18 with metastatic pancreatic ductal adenocarcinoma who haven't had prior GEM/NAB-P treatment can join. They need good organ function, no recent other cancers except certain skin or localized prostate cancer, and must not have uncontrolled health issues like heart disease. Participants should be able to take oral medication and agree to use contraception.Check my eligibility

What is being tested?

The trial is testing Proglumide (1200 mg daily) combined with standard chemotherapy (Gemcitabine and Nab-paclitaxel) against a placebo plus the same chemo regimen in patients with advanced pancreatic cancer. The initial phase checks for safety before moving on to a larger Phase 2 study.See study design

What are the potential side effects?

Possible side effects include digestive issues due to Proglumide, typical chemotherapy-related symptoms such as fatigue, nausea, low blood counts leading to increased infection risk, liver function changes, and potential allergic reactions.

ProGem Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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Your blood counts, liver and kidney function are within normal levels.

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I have never received treatments with GEM or NAB-P.

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My cancer can be measured and biopsied according to specific criteria.

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My cancer is a type of pancreatic cancer that has spread to other parts of my body.

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I am post-menopausal or not pregnant if pre-menopausal.

ProGem Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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

Safety of oral proglumide therapy at 1200mg daily dose with chemotherapy

Secondary outcome measures

Effects of proglumide on Pain

Fibrosis in the pancreatic tumor microenvironment

Overall survival (OS)

+1 more

ProGem Trial Design

2Treatment groups

Experimental Treatment

Group I: Proglumide TID with Gemcitabine and Nab-PaclitaxelExperimental Treatment3 Interventions

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

Group II: Placebo TID with Gemcitabine and Nab-PaclitaxelExperimental Treatment3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Proglumide

2019

Completed Phase 1

~30

Gemcitabine

2017

Completed Phase 3

~2070

Nab paclitaxel

2014

Completed Phase 2

~70

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor

343 Previous Clinical Trials

136,472 Total Patients Enrolled

Benjamin Weinberg, MDPrincipal InvestigatorGeorgetown University

5 Previous Clinical Trials

167 Total Patients Enrolled

Media Library

Pancreatic Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT05827055 — Phase 2

Frequently Asked Questions

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

Is recruitment still open for the clinical trial?

"Data posted on clinicaltrials.gov confirms that, at the time of this inquiry, recruitment for this study has ceased. This trial was initially made available to prospective participants on July 1st 2023 and last updated April 11th 2023; however 1278 other trials are actively searching for patients."

Answered by AI

Is there evidence that suggests using Proglumide TID with Gemcitabine and Nab-Paclitaxel at Dose Level 1 is a safe practice?

"Given that there is only limited data available pertaining to the safety and efficacy of Dose Level 1: Proglumide TID with Gemcitabine and Nab-Paclitaxel, our team at Power assigned a score of one for this drug."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Proglumide and Chemotherapy for Metastatic Pancreatic Cancer

2024. "Proglumide and Chemotherapy for Metastatic Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05827055.