Olaparib in Subjects With Advanced Pancreatic Acinar Cell Carcinoma (NCT05286827) | Clinical Trial Compass
TerminatedPhase 2
Olaparib in Subjects With Advanced Pancreatic Acinar Cell Carcinoma
Stopped: The study was terminated due to low accrual and insufficient efficacy seen in first few participants treated.
United States5 participantsStarted 2023-12-14
Plain-language summary
Background:
Pancreatic Acinar Cell Carcinoma (PACC) is a rare pancreatic tumor. People with PACC usually present with advanced disease, and their prognosis is poor. Researchers want to learn if a cancer drug called olaparib can help.
Objective:
To see if olaparib is an effective treatment for PACC.
Eligibility:
People aged 18 and older with PACC whose cancer did not respond to previous treatments or is not eligible for surgery.
Design:
Participants will be screened with the following:
Medical history
Physical exam
Blood and urine tests
Electrocardiogram (to test heart function)
Computed tomography (CT) scans
Pregnancy test (if needed)
Tumor biopsy (if a sample is not available)
Treatment will be given in 28-day cycles. Participants will take olaparib by mouth twice daily for each cycle. They will keep a medicine diary. They will receive treatment for up to 2 years. They may stop treatment early if their cancer gets worse or they have serious side effects.
Participants will have study visits at the beginning of each cycle. At visits, they will repeat some screening tests. They will be asked about any changes in medicines they are taking and how they are feeling. They will have CT scans every 8 weeks starting in cycle 2.
Participants will give blood samples for research. They may have optional tumor biopsies.
Participants will have 2 follow-up visits in the 30 days after treatment ends or before they begin a new anti-cancer treatment. Then they will be contacted every 3 months by phone for 1 year.
Participation will last for up to 3 years.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histological or cytological diagnosis of pancreatic acinar cell carcinoma (PACC) as confirmed by National Institutes of Health (NIH) Laboratory of Pathology (LP).
✓. Participants must have received one prior line of combination chemotherapy (or be ineligible to receive combination chemotherapy) with tumor still not amenable for potentially curative resection or be ineligible to receive combination chemotherapy. There is no limit on the number of prior therapies.
✓. Access to medical records from past treatment
✓. Measurable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
✓. Age \>=18 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status \<=1.
✓. At least 3 weeks from previous chemotherapy or radiation therapy prior to planned start of treatment.
✓. At least 30 days or 5 half-lives (whichever is greater) since receipt of any investigational therapy prior to planned start of treatment.
Exclusion criteria
What they're measuring
1
Proportion of Participants With Partial Response (PR) or Complete Response (CR) Reported Along With a 95% Two-sided Confidence Interval
Timeframe: 1-year
2
Proportion of Participants With Partial Response or Complete Response Reported Along With a 80% Two-sided Confidence Interval
✕. History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib.
✕. Participants unable to swallow orally administered medication or suffering from gastrointestinal (GI) disorders likely to interfere with absorption of study medication.
✕. Participants with human immunodeficiency virus (HIV) are excluded even if viral load is undetectable
✕. Active hepatitis B (HBV) or hepatitis C virus (HCV)
✕. Resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QT corrected by Fridericia's formula (QTcF) prolongation \>500 ms, electrolyte disturbances, etc.), or participants with congenital long QT syndrome.