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TERMINATED
NCT05286827
PHASE2

Olaparib in Subjects With Advanced Pancreatic Acinar Cell Carcinoma

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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.

Official title: Phase II Study of Olaparib in Subjects With Advanced Pancreatic Acinar Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

5

Start Date

2023-12-14

Completion Date

2025-09-25

Last Updated

2026-08-14

Healthy Volunteers

No

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)

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States