Pancreatic Acinar Cell CarcinomaPhase 2NCT05286827
Olaparib in Subjects With Advanced Pancreatic Acinar Cell Carcinoma
A Phase 2 study testing Olaparib, ECG and CT CAP in people with Pancreatic Acinar Cell Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Acinar Cell Carcinoma
- What is being tested?
- Olaparib, ECG and CT CAP
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2023to 25 Sep 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib.
- Participants unable to swallow orally administered medication or suffering from gastrointestinal (GI) disorders likely to interfere with absorption of study medication.
- Participants with human immunodeficiency virus (HIV) are excluded even if viral load is undetectable
- Active hepatitis B (HBV) or hepatitis C virus (HCV)
- 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.
- Recent (within 3 months) myocardial infarction
Show all 21Show fewer
- Unstable angina pectoris.
- Symptomatic congestive heart failure
- Uncontrolled major seizure disorder
- Superior vena cava syndrome
- Extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan
- Psychiatric illness/social situations (within the last 3 months) that would limit compliance with study requirements or prohibits obtaining informed consent
- 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
- Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
- 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.
- Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
- Participants who are nursing and unwilling to stop.
- 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.
- 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.
- Participants with large volume ascites, serum albumin < 2.5 mg/dL, or having received paracentesis within the last 4 weeks
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Phase II Study of Olaparib in Subjects With Advanced Pancreatic Acinar Cell Carcinoma
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.
Read more
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.
Read the detailed description
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 deoxyribonucleic acid (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 Food and Drug Administration (FDA) approved for the treatment of BReast CAncer genes 1 and 2 (BRCA)-mutant homologous recombination repair (HRR) deficient cancers.
- As PACC has multiple hallmarks of homologous recombination repair (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.
- Conditions
- Pancreatic Acinar Cell Carcinoma
- Being tested
- Olaparib, ECG, CT CAP, Tumor Biopsy
- Keywords
- Poly-Adp Ribose Polymerase (Parp)-1 Inhibitor, Homologous Recombination Repair, Platinum-Sensitive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaparibDrug
Also called Lynparza
Administered orally (300 mg) twice daily continuously for 28-day cycles as clinically indicated.
ECGDiagnostic test
Also called Electrocardiogram
Screening.
CT CAPDiagnostic test
Also called Computed tomography chest, abdomen, and pelvis
Screening. Baseline Cycle 1, Day 1 (≤7 days), and subsequent Cycles, Day 1 (+/- 7 days) every 8 weeks.
Tumor BiopsyProcedure or surgery
Also called Tumor Bx
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)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Cohort 1 Olaparib in Pancreatic Acinar Cell Carcinoma | Experimental | Olaparib, taken orally, twice daily Receives: Drug: Olaparib; Diagnostic Test: ECG; Diagnostic Test: CT CAP; Procedure: Tumor Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Partial Response (PR) or Complete Response (CR) Reported Along With a 95% Two-sided Confidence Interval
Objective response rate (ORR) is defined as the proportion of participants with partial response or complete response reported along with a 95% two-sided confidence interval. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Measured: 1-year
Proportion of Participants With Partial Response or Complete Response Reported Along With a 80% Two-sided Confidence Interval
Objective response rate (ORR) is defined as the proportion of participants with partial response or complete response reported along with an 80% two-sided confidence interval. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Measured: 1-year
Secondary outcomes (6)
Percentage of Participants With Partial Response, Complete Response, and/or Stable Disease Reported Along With a 95% Confidence Interval
Disease control rate is defined as the percentage of participants with partial response, complete response, and/or stable disease. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of diameters while on study. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.
Measured: 1-year
Number of Treatment-related Serious Adverse Events by Grade and Type as Defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Here is the number of treatment-related serious adverse events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse events.
Measured: From start of treatment to 30 days after last treatment, up to an average of 30 days
Median Duration of Treatment Response
Median duration of treatment responses will be reported using the Kaplan-Meier method from the date a response is identified until the date a response ends (by progression or other reason), or the response is continuing, in which case the duration will be censored. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of diameters while on study. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.
Measured: 1-year after response noted
Median Progression-free Survival (PFS) Reported Along With a 95% Confidence Interval
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. PFS will be determined using the Kaplan-Meier method and will be reported along with a 95% confidence interval. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.
Measured: Calculated from on-study date until the date of progression or death without progression as events with participants censored if they do not have an event by the date of last known follow-up, an average of 1.6 months.
Median Overall Survival (OS) Reported Along With a 95% Confidence Interval
Overall survival (OS) is defined as the length of time from start of treatment until death from any cause estimated using the Kaplan-Meier method.
Measured: Calculated from the on-study date until the date of death, an average of 11 months.
Months to Best Response in Participants Assessed Using Serum Lipase (Tumor Marker in Pancreatic Acinar Cell Carcinoma)
Best response in serum lipase (tumor marker in pancreatic acinar cell carcinoma) was assessed for each treated participant (defined as greatest decrease from baseline measurement during the treatment course) tested for statistical significance of the change by a Wilcoxon signed rank test with a two-tailed p-value, and the median and full range was calculated.
Measured: Calculated at baseline and assessed every 28 days for an average of 0.158 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start14 Dec 2023
- Primary completion18 Dec 2024
- Study completion25 Sep 2025
Why it stopped: The study was terminated due to low accrual and insufficient efficacy seen in first few participants treated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic Acinar Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Chen Zhao, National Cancer Institute (NCI)
- Investigators
- Chen Zhao, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286827
- Sponsor's protocol ID
- 10000596
- Other IDs
- 000596-C
- Status last verified
- Jul 2026
- First submitted
- 12 Mar 2022
- Last updated
- 14 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Olaparib in Subjects With Advanced Pancreatic Acinar Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05286827
- Acronym / sponsor ID
- 10000596
- Conditions
- Pancreatic Acinar Cell Carcinoma
- Keywords
- Poly-Adp Ribose Polymerase (Parp)-1 Inhibitor, Homologous Recombination Repair, Platinum-Sensitive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to low accrual and insufficient efficacy seen in first few participants treated.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Posted 11 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 deoxyribonucleic acid (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 Food and Drug Administration (FDA) approved for the treatment of BReast CAncer genes 1 and 2 (BRCA)-mutant homologous recombination repair (HRR) deficient cancers.
- As PACC has multiple hallmarks of homologous recombination repair (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Cohort 1 Olaparib in Pancreatic Acinar Cell Carcinoma | Experimental | Drug: Olaparib, Diagnostic Test: ECG, Diagnostic Test: CT CAP, Procedure: Tumor BiopsyOlaparib, taken orally, twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib.
- Participants unable to swallow orally administered medication or suffering from gastrointestinal (GI) disorders likely to interfere with absorption of study medication.
- Participants with human immunodeficiency virus (HIV) are excluded even if viral load is undetectable
- Active hepatitis B (HBV) or hepatitis C virus (HCV)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlaparibAlso: LynparzaAdministered orally (300 mg) twice daily continuously for 28-day cycles as clinically indicated. | Drug | Arm 1 Cohort 1 Olaparib in Pancreatic Acinar Cell Carcinoma |
| ECGAlso: ElectrocardiogramScreening. | Diagnostic test | Arm 1 Cohort 1 Olaparib in Pancreatic Acinar Cell Carcinoma |
| CT CAPAlso: Computed tomography chest, abdomen, and pelvisScreening. Baseline Cycle 1, Day 1 (≤7 days), and subsequent Cycles, Day 1 (+/- 7 days) every 8 weeks. | Diagnostic test | Arm 1 Cohort 1 Olaparib in Pancreatic Acinar Cell Carcinoma |
| Tumor BiopsyAlso: Tumor BxOptional. 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) | Procedure or surgery | Arm 1 Cohort 1 Olaparib in Pancreatic Acinar Cell Carcinoma |
Primary outcome
Proportion of Participants With Partial Response (PR) or Complete Response (CR) Reported Along With a 95% Two-sided Confidence Interval
Time frame: 1-year
Objective response rate (ORR) is defined as the proportion of participants with partial response or complete response reported along with a 95% two-sided confidence interval. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Proportion of Participants With Partial Response or Complete Response Reported Along With a 80% Two-sided Confidence Interval
Time frame: 1-year
Objective response rate (ORR) is defined as the proportion of participants with partial response or complete response reported along with an 80% two-sided confidence interval. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
6 secondary outcomes
Percentage of Participants With Partial Response, Complete Response, and/or Stable Disease Reported Along With a 95% Confidence Interval
Time frame: 1-year
Number of Treatment-related Serious Adverse Events by Grade and Type as Defined by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: From start of treatment to 30 days after last treatment, up to an average of 30 days
Median Duration of Treatment Response
Time frame: 1-year after response noted
Median Progression-free Survival (PFS) Reported Along With a 95% Confidence Interval
Time frame: Calculated from on-study date until the date of progression or death without progression as events with participants censored if they do not have an event by the date of last known follow-up, an average of 1.6 months.
Median Overall Survival (OS) Reported Along With a 95% Confidence Interval
Time frame: Calculated from the on-study date until the date of death, an average of 11 months.
Months to Best Response in Participants Assessed Using Serum Lipase (Tumor Marker in Pancreatic Acinar Cell Carcinoma)
Time frame: Calculated at baseline and assessed every 28 days for an average of 0.158 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Zhao, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Olaparib, ECG and CT CAP in people with Pancreatic Acinar Cell Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Partial Response (PR) or Complete Response (CR) Reported Along With a 95% Two-sided Confidence Interval (time frame: 1-year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.