Study on Olaparib for Treating Advanced Pancreatic Acinar Cell Carcinoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05286827

Provider View

This clinical trial is exploring whether the drug olaparib can be an effective treatment for people with advanced Pancreatic Acinar Cell Carcinoma (PACC) that has not responded to previous treatments or cannot be treated with surgery.

Patient Parameters

Program Overview

Pancreatic Acinar Cell Carcinoma (PACC) is a rare type of pancreatic cancer that often presents at an advanced stage, making it difficult to treat. This study aims to find out if olaparib, a drug that targets specific cancer cell weaknesses, can help treat PACC. Participants will take olaparib by mouth twice a day in 28-day cycles for up to two years, unless their cancer worsens or they experience severe side effects. The study will involve regular check-ups and tests to monitor the participants' health and the effectiveness of the treatment.

Description

Pancreatic Acinar Cell Carcinoma (PACC) is a rare form of pancreatic cancer, making up only 0.5-1% of all pancreatic cancers. It is often diagnosed at an advanced stage, and the outlook for patients is generally poor. Unlike other types of pancreatic cancer, PACC has unique characteristics that may make it more responsive to certain treatments.

Olaparib is a drug that has been approved for treating other cancers with specific genetic mutations. It works by blocking a protein that cancer cells need to repair themselves, potentially making them more vulnerable to treatment. This study is testing whether olaparib can be effective for PACC, which shares some of these genetic vulnerabilities.

Participants in this study will take olaparib twice daily for up to two years. They will have regular visits to monitor their health and the cancer's response to the treatment. These visits will include medical exams, blood tests, and scans. Participants will also keep a diary to track their medication use and any side effects. The study will continue until the cancer progresses or the participant experiences intolerable side effects.

The study will enroll up to 13 participants who meet specific criteria, including having advanced PACC that has been previously treated. Participants will be closely monitored for safety and the effectiveness of the treatment every eight weeks. The study aims to provide new insights into whether olaparib can be a viable treatment option for this rare cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Pancreatic Acinar Cell Carcinoma (PACC).
  • Have received at least one prior treatment for PACC, or are not eligible for combination chemotherapy.
  • Cancer cannot be surgically removed.
  • Age 18 years or older.
  • Good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • At least three weeks since last chemotherapy or radiation treatment.
  • At least 30 days since any investigational therapy.
  • Fully recovered from any recent surgeries.
  • Not taking certain medications that could interfere with the study drug.
  • Adequate blood cell counts and organ function as determined by specific tests.
  • Agree to use effective contraception during the study and for a period after.
  • Willing to avoid grapefruit juice during the study.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • Allergic to olaparib or similar drugs.
  • Unable to swallow pills or have digestive issues that affect medication absorption.
  • Have HIV, active hepatitis B or C.
  • Have certain heart conditions or recent heart attack.
  • Have uncontrolled seizures or other serious medical conditions.
  • Have another type of cancer unless treated and disease-free for at least 5 years.
  • Have had a bone marrow transplant.
  • Pregnant or breastfeeding women.
  • Have uncontrolled brain metastases or spinal cord compression.
  • Have large amounts of fluid in the abdomen or low serum albumin.
  • Have ongoing severe side effects from previous cancer treatments.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.