Cancer drug olaparib tested for rare pancreatic tumor
NCT ID NCT05286827
First seen Jun 26, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This phase 2 trial tested the drug olaparib (Lynparza) in people with advanced pancreatic acinar cell carcinoma, a rare pancreatic cancer. Participants took olaparib pills twice daily for up to 2 years. The study was terminated early after enrolling only 5 people, so it is not known if the drug helps.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Olaparib (Lynparza)
- What this could lead to
- If it works, this could point toward a treatment option for a rare and hard-to-treat pancreatic cancer.
- What could go wrong
- The trial was terminated early with only 5 participants, so results are very limited. It is unclear if olaparib is effective for this cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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5 people
The number who actually took part.
- Started
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Dec 2023
- Finished
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Sep 2025
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
-INCLUSION CRITERIA: 1. Histological or cytological diagnosis of pancreatic acinar cell carcinoma (PACC) as confirmed by National Institutes of Health (NIH) Laboratory of Pathology (LP). 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 Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. 5. Age \>=18 years. 6. Eastern Cooperative Oncology Group (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 sequelae 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 cytochrome P450 (CYP) (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) * Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) \<= institutional ULN unless liver metastases are present in which case they may be \<=5x ULN * Creatinine must be within normal range, OR \>=51 mL/min per the formula below\* 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, individuals of child-bearing potential (IOCBP) and individual able to father a child 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 participant to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: 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 gastrointestinal (GI) disorders likely to interfere with absorption of study medication. 3. Participants with human immunodeficiency virus (HIV) are excluded even if viral load is undetectable 4. Active hepatitis B (HBV) or hepatitis C virus (HCV) 5. 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. 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. Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) 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. Participants who are nursing and unwilling to stop. 18. 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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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