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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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.