Study on Galeterone or Galeterone with Gemcitabine for Patients with Advanced Pancreatic Cancer

Sponsor: University of Maryland, Baltimore

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04098081

Provider View

This clinical trial is testing the effectiveness of a new drug, galeterone, alone or combined with chemotherapy, for treating advanced pancreatic cancer. The study aims to see if these treatments can help control the disease.

Patient Parameters

Program Overview

This study is a Phase II clinical trial, which means it is testing the safety and effectiveness of galeterone, a new drug, in treating pancreatic cancer. Galeterone is not yet approved by the FDA for this type of cancer. It works by blocking certain receptors that may help cancer grow. Researchers want to find out if galeterone alone or with chemotherapy can help treat pancreatic cancer.

Description

This research study is focused on testing a new drug called galeterone, which is being investigated for its potential to treat pancreatic cancer. Galeterone is an androgen receptor inhibitor, meaning it blocks certain signals that may help cancer cells grow. Although it has shown promise in lab studies, it is not yet approved by the FDA for pancreatic cancer treatment. This study will explore whether galeterone alone or in combination with chemotherapy can effectively treat patients with advanced pancreatic cancer. Participants will receive either galeterone by itself or galeterone with a chemotherapy drug called gemcitabine, and researchers will monitor their response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and sign a consent form.
  • Agree to follow study requirements and attend clinic visits.
  • Must be 18 years or older.
  • Have a confirmed diagnosis of pancreatic cancer that has spread.
  • Have measurable cancer that can be seen on scans.
  • Have tried at least two previous treatments that did not work, and have not had chemotherapy for at least four weeks before starting the study.
  • Be in good general health with a performance status score of 0 to 2.
  • Must use effective birth control during the study to prevent pregnancy.
  • Able to swallow pills.
  • Expected to live for more than 12 weeks.
  • Have adequate blood cell counts and organ function based on specific blood tests.
  • Patients with well-controlled brain metastases are eligible.

Exclusion Criteria

  • Participating in another clinical trial for pancreatic cancer within four weeks before joining this study.
  • Previous treatment with galeterone or similar drugs.
  • Recent major surgery or radiation therapy.
  • Certain heart conditions or recent heart problems.
  • Active or chronic liver disease, including hepatitis B or C.
  • HIV infection.
  • Uncontrolled high or low blood pressure.
  • History of adrenal gland problems.
  • Gastrointestinal issues that affect drug absorption.
  • Serious infections or uncontrolled medical conditions.
  • History of seizures or conditions that increase seizure risk.
  • Recent loss of consciousness or mini-strokes.
  • Other cancers within the past five years, except for certain skin or bladder cancers.
  • Known allergies to study drugs.
  • Conditions that may interfere with study participation.
  • Current alcohol or drug abuse.
  • Pregnant or breastfeeding women.
  • Women of childbearing age must have a negative pregnancy test before joining the study.

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