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Olaparib in Subjects With Advanced Pancreatic Acinar Cell Carcinoma

NCT05286827 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-03-11

Study results available
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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.

Conditions

  • Pancreatic Acinar Cell Carcinoma

Interventions

DRUG

Olaparib

Administered orally (300 mg) twice daily continuously for 28-day cycles as clinically indicated.

DIAGNOSTIC_TEST

ECG

Screening.

DIAGNOSTIC_TEST

CT CAP

Screening. Baseline Cycle 1, Day 1 (≤7 days), and subsequent Cycles, Day 1 (+/- 7 days) every 8 weeks.

PROCEDURE

Tumor Biopsy

Optional. Baseline Cycle 1, Day 1 (≤7 days), subsequent Cycles, Day 1 (+/- 7 days; once only, Cycle 2 preferred), and end of treatment (14-30 days after last treatment)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Anish Thomas, MBBS, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-14
Primary Completion
2024-12-18
Completion
2025-09-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05286827 on ClinicalTrials.gov