Study on Minnelide for Treating Advanced Pancreatic Cancer (ASCP)

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04896073

Provider View

This clinical trial is testing a new drug called Minnelide to see if it can help treat a rare and aggressive type of pancreatic cancer known as adenosquamous carcinoma of the pancreas (ASCP). The study is for adults whose cancer has not responded to previous treatments.

Patient Parameters

Program Overview

Pancreatic cancer is one of the deadliest cancers, and ASCP is a particularly aggressive and rare form of it. Researchers are investigating whether a drug called Minnelide can be effective in treating ASCP. The study aims to determine if Minnelide can control the disease in adults aged 18 and older who have not responded to other treatments. Participants will undergo various tests, including medical history, physical exams, and scans, to ensure they are eligible. They will take Minnelide orally for 21 days in a 28-day cycle, with a 7-day break between cycles, for up to 12 cycles. Regular study visits will monitor their progress, and some may need to use birth control during and after the study.

Description

Adenosquamous carcinoma of the pancreas (ASCP) is a rare and aggressive type of pancreatic cancer. It accounts for a small percentage of pancreatic cancer cases in the U.S. each year. This study is the first of its kind to focus on ASCP. Researchers have found that a network of changes in the cancer cells drives its aggressive nature. Minnelide is a drug that targets these changes and has shown promise in early tests.

The main goal of this study is to see if Minnelide can control the disease in patients with advanced ASCP who have already tried other treatments. Participants will take Minnelide daily for 21 days in a 28-day cycle, with a 7-day rest period, for up to 12 cycles. The study will monitor how well the drug works by checking the size of the tumors every 8 weeks. Optional biopsies may be requested to gather more information about the cancer.

The study will start with 12 participants, and if at least 3 show a positive response, more participants will be added to better understand the drug's effectiveness. The study aims for a disease control rate of 40% or higher in this challenging patient group.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of ASCP or a high suspicion of ASCP based on specific tests.
  • Have cancer that has spread or cannot be removed by surgery and has not responded to at least one previous treatment.
  • Have measurable disease based on standard criteria.
  • Show signs of disease progression, such as increasing tumor size or worsening symptoms.
  • Be in good overall health with a performance status score of less than 2.
  • Agree to provide informed consent and follow study procedures.
  • Have adequate organ and blood function as determined by specific tests.
  • Women of childbearing potential and men must agree to use effective contraception during the study and for a specified period after the last dose.

Exclusion Criteria

  • Cannot take the study drug orally due to medical conditions.
  • Pregnant or breastfeeding women.
  • Currently participating in another clinical trial or have recently received certain treatments.
  • Require certain medications that are not allowed in the study.
  • Have had major surgery or certain procedures recently.
  • Have another active cancer that requires treatment.
  • Have active brain metastases or certain brain conditions.
  • Have an active infection requiring treatment.
  • Have conditions or disorders that could interfere with the study.
  • Have uncontrolled HIV, hepatitis B, or hepatitis C infections.
  • Have received a live vaccine recently.
  • Have a history of allergic reactions to similar drugs.

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