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Protocol Details

Phase II Study of Olaparib in Subjects with Advanced Pancreatic Acinar Cell Carcinoma

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)

Pregnant Women;


Poly-Adp Ribose Polymerase (Parp)-1 Inhibitor;
Homologous Recombination Repair;

Recruitment Keyword(s)



Pancreatic Acinar Cell Carcinoma

Investigational Drug(s)


Investigational Device(s)



Drug: Olaparib

Supporting Site

National Cancer Institute


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.


To see if olaparib is an effective treatment for PACC.


People aged 18 and older with PACC whose cancer did not respond to previous treatments or is not eligible for surgery.


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 21-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.

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1. Histological or cytological diagnosis of Pancreatic Acinar Cell Carcinoma (PACC) as confirmed by NIH Laboratory of Pathology.

2. 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.

3. Access to medical records from past treatment

4. Measurable disease, per RECIST 1.1.

5. Age >=18 years.

6. ECOG performance status <=1.

7. At least 3 weeks from previous chemotherapy or radiation therapy prior to planned start of treatment.

8. At least 30 days or 5 half-lives (whichever is greater) since receipt of any investigational therapy prior to planned start of treatment.

9. Fully recovered from all reversible sequalae and >=2 weeks from major surgery or from minor surgical procedure such as biliary or duodenal stenting prior to planned start of treatment.

10. At least 2 weeks since last use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil).

11. At least 5 weeks since last use of phenobarbital, enzalutamide, and at least 3 weeks since last use of other strong (e.g., phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John s Wort) or moderate (e.g., bosentan, efavirenz, modafinil) CYP3A inducers.

12. Adequate organ and marrow function as measured within 28 days prior to study treatment as defined below:

- leukocytes >=3,000/mcL

- absolute neutrophil count >=1,500/mcL

- hemoglobin >= 10 g/dL with no blood transfusion within the last 28 days

- platelets >=100,000/mcL

- total bilirubin within 1.5x normal institutional upper limit of normal (ULN)

- AST(SGOT)/ALT(SGPT) <= institutional ULN unless liver metastases are present in which case they may be <=5x ULN

- Creatinine clearance must be >51 mL/min as estimated using the Cockroft-Gault equation* or measured by 24- hour urine test

*Estimated creatinine clearance = (140-age [years]) x weight (kg) (x F) serum/ creatinine (mg/dL) x 72^a, where F=0.85 for females and F=1 for males

This list includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.

13. The effects of olaparib on the developing human fetus are unknown. For this reason and because PARP inhibitor agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

14. Participants must agree to abstain from consuming grapefruit juice throughout the duration of study treatment with olaparib.

15. Ability of subject to understand and the willingness to sign a written informed consent document.


1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib.

2. Participants unable to swallow orally administered medication or suffering from GI disorders likely to interfere with absorption of study medication.

3. Participants with HIV are excluded even if viral load is undetectable

4. Active hepatitis B or C

5. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances, etc.), or participants with congenital long QT syndrome.

6. Recent (within 3 months) myocardial infarction

7. Unstable angina pectoris.

8. Symptomatic congestive heart failure

9. Uncontrolled major seizure disorder

10. Superior vena cava syndrome

11. Extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan

12. Psychiatric illness/social situations (within the last 3 months) that would limit compliance with study requirements or prohibits obtaining informed consent

13. Uncontrolled intercurrent illness or participants considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active uncontrolled infection as documented in prior records or suggested by medical history, physical examination or standard clinical assessments such as imaging and laboratory studies

14. Participants with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.

15. Solid or liquid malignancy other than PACC unless curatively treated with no evidence of disease for >=5 years, except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.

16. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).

17. Women who are breastfeeding and unwilling to stop.

18. Participants with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. Brain metastases are considered uncontrolled if the dose of corticosteroid being provided for control of brain metastases has been titrated in the 4 weeks prior to start of treatment.

19. Participants with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for >=28 days. Participants with unstable spinal cord compression are ineligible even if previously treated.

20. Participants with large volume ascites, serum albumin < 2.5 mg/dL, or having received paracentesis within the last 4 weeks

21. Participants with persistent toxicities > grade 2 or with new grade 2 events within the last 2 weeks per Common Terminology Criteria for Adverse Event (CTCAE) version 5 caused by previous cancer therapy.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Christine C. Alewine, M.D.
National Cancer Institute (NCI)
NIHBC 37 BG RM 5116B
(240) 760-6146

NCI Medical Oncology Referral Office
National Cancer Institute (NCI)

(888) 624-1937

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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