Study on Proglumide and Chemotherapy for Metastatic Pancreatic Cancer

Sponsor: Georgetown University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05827055

Provider View

This clinical trial is testing a combination of standard chemotherapy and a new drug, proglumide, to see if it can help treat metastatic pancreatic cancer. The study will first check the safety of proglumide before moving to a larger trial phase.

Patient Parameters

Program Overview

This study aims to test a new treatment for metastatic pancreatic cancer by combining standard chemotherapy drugs, gemcitabine and nab-paclitaxel, with a new drug called proglumide. Initially, a small group of patients will receive proglumide to ensure it is safe. If successful, more patients will be enrolled to further test the treatment's effectiveness. Participants will undergo regular health checks, including blood tests and scans, to monitor their response to the treatment.

Description

The study begins with a small group of patients receiving proglumide alongside standard chemotherapy to ensure the combination is safe. If this phase is successful, the study will expand to include more patients. Participants will be randomly assigned to receive either the standard chemotherapy with a placebo or with proglumide at the dose found safe in the initial phase.

Throughout the study, patients will have regular blood tests, physical exams, and scans to monitor their health and the treatment's effects. If any side effects occur, the dose of proglumide may be adjusted. Tumor biopsies will be taken before starting treatment and at week 8 to study the tumor environment. The study will last for 24 weeks or until the cancer progresses, side effects become too severe, or treatment is no longer needed.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Be over 18 years old.
  • Have normal organ and bone marrow function, as shown by specific blood tests.
  • Women must be post-menopausal or have a negative pregnancy test.
  • Have measurable cancer that can be biopsied.
  • Have not received previous treatment with gemcitabine or nab-paclitaxel.
  • Have metastatic pancreatic cancer confirmed by biopsy.
  • Be willing to follow the study protocol, including attending all visits and tests.

Exclusion Criteria

  • Have another type of cancer or had one in the last 3 years, except for certain skin or cervical cancers.
  • Have uncontrolled heart disease or had a heart attack in the last 6 months.
  • Cannot safely stop blood thinners for a biopsy.
  • Have poorly controlled medical conditions like asthma or diabetes.
  • Are pregnant or breastfeeding.
  • Are not willing to use effective birth control during the study and for 6 months after.
  • Are receiving other cancer treatments.
  • Had major surgery in the last 28 days.
  • Have had an organ transplant.
  • Have serious ongoing illnesses or infections.
  • Have active infections like tuberculosis, hepatitis B or C, or HIV.
  • Have received a live vaccine in the last 30 days.
  • Have allergies to the study drugs.
  • Cannot swallow pills or have a condition that affects absorption of the medication.

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