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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05286827.
Background:
- Pancreatic Acinar Cell Carcinoma (PACC) is a rare pancreatic tumor, representing
0.5-1% of all pancreatic malignancies.
- PACC is commonly advanced at presentation and median overall survival in this
population is poor.
- PACC is pathologically and biochemically distinct from pancreatic adenocarcinoma.
- No clinical trials for PACC have ever been reported.
- Patients are most commonly treated with combination regimens used for either
pancreatic or colon adenocarcinoma with poor (approximately 30%) response rates in
the first-line setting.
- PACC pathological specimens demonstrate evidence of high chromosomal instability, a
hallmark of DNA repair deficiency.
- Data derived from ovarian and prostate cancer patients has demonstrated that
mutations in DNA repair genes can define subgroups of cancer patients with distinct
vulnerabilities to DNA damage response inhibitors.
- Olaparib is a Poly-ADP ribose polymerase (PARP)-1 inhibitor that has been FDA
approved for the treatment of BRCA-mutant homologous recombination repair (HRR)
deficient cancers.
- As PACC has multiple hallmarks of HRR deficiency, we hypothesize that PACC will be
sensitive to PARP inhibition with olaparib.
- Pre-clinical modeling of PACC has been very limited with no currently available
animal models or cell lines, which precludes testing this hypothesis in the
laboratory setting.
Objective:
- To assess the anti-tumor activity of single agent olaparib, a PARP inhibitor, in
participants with advanced pancreatic acinar cell carcinoma (PACC)
Eligibility:
- Participants must have advanced previously treated PACC
- Age >=18 years
- Adequate organ and bone marrow function
Design:
- This is a phase II, single arm, single center study of olaparib in participants with
advanced previously treated PACC.
- All participants will take olaparib by mouth twice daily for up to two years or
until disease progression or intolerable side effects.
- Participants will be assessed for safety (continuously) and efficacy (every 8
weeks).
- Up to 13 evaluable participants will be enrolled.
Lead OrganizationNational Cancer Institute
Principal InvestigatorChristine Campo Alewine