Pancreatic CancerPhase 2NCT03601923
Niraparib in Patients With Pancreatic Cancer
A Phase 2 study testing Niraparib in people with Pancreatic Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
This research study is studying an investigational therapy as a possible treatment for pancreatic cancer. The drugs involved in this study are: -Niraparib Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Niraparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Aug 2018to 28 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Participants must have a histologically confirmed advanced pancreatic adenocarcinoma that is not curable with standard approaches. Patients with metastatic pancreatic cancer and unresectable pancreatic cancer are eligible.
- Patients must have molecular characteristics that fulfill one of the following requirements:
- Germline deleterious BRCA1, BRCA2, PALB2, CHEK2 or ATM mutations. Germline variants of unknown significance are not eligible.
- Somatic mutation in BRCA1, BRCA2, PALB2, CHEK2 or ATM
- Germline and somatic testing need to be performed in CLIA approved laboratories. Deleterious genetic mutations should either be described in the literature or felt by expert opinion (in consultation with the principal investigator) to interfere with the protein's DNA repair function. The somatic mutational testing can be performed on tissue samples taken from any time in the patient's pancreatic cancer history.
- Patients must have received at least one line of treatment for their cancer prior to enrolling on the trial.
Show all 30Show fewer
- Patients who had investigator assessed progression on an oxaliplatin-containing regimen (such as FOLFOX or FOLFIRINOX) are not eligible for the trial.
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
- Age ≥ 18 years. As no dosing or adverse event data are currently available in participants < 18 years of age, children are excluded from this study.
- ECOG performance status of 0 or 1 (see Appendix A)
- Participants must have adequate organ and marrow function as defined below:
- Absolute neutrophil count ≥ 1,500/mm3
- Platelets ≥ 100,000/mm3
- Hemoglobin ≥ 9g/dL
- Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
- Serum creatinine ≤ 1.5 × institutional ULN -OR-
- Creatinine clearance ≥ 30 mL/min/1.73 m2 for participants with serum creatinine levels above the institutional ULN
- Albumin ≥ 2.7 g/dL
- Female participants must have a negative serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of nonchildbearing potential. Nonchildbearing potential is defined as follows (by other than medical reasons):
- --≥45 years of age and has not had menses for >1 year
- Patients who have been amenorrhoeic for <2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range (>35μlU/mL) upon screening evaluation
- Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 180 days after the last dose of study treatment. See Section 5.5 for a list of acceptable birth control methods. Information must be captured appropriately within the site's source documents. --Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
- Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment.
- Male participant agrees to use an adequate method of contraception (see Section 5.5 for a list of acceptable birth control methods) starting with the first dose of study treatment through 180 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
- Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
- Ability to swallow and retain oral medication.
- Ability to understand and the willingness to sign a written informed consent document.
- Participants must be willing to undergo a pre-treatment fresh tumor biopsy. The biopsy requirement can be waived only after discussion with the principal investigator.
- Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy.
Who cannot join
- Participants who have had cytotoxic chemotherapy, radiotherapy, immunotherapy, biologic therapy, or other investigational therapy within 2 weeks prior to entering the study or those who have not recovered to ≤ CTCAE (version 5.0) Grade 1 or baseline from adverse events due to agents administered more than 2 weeks earlier (with the exceptions of alopecia and peripheral neuropathy).
- Participants must not have received investigational therapy administered ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior initiating protocol therapy.
- Participants who have received oral targeted therapy or tyrosine kinase inhibitor (TKI) therapy within 5 half-lives or 2 weeks of study entry, whichever is shorter.
- Participants who have been previously treated with a PARP inhibitor.
- Participant has had radiation therapy encompassing >20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.
- Participants who have undergone major surgery ≤ 3 weeks prior to initiating protocol therapy. Participants must have sufficiently recovered from adverse events caused by the procedure as judged by the treating investigator.
Show all 19Show fewer
- Participants with known untreated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Participants with a history of brain metastases that have been treated, are no longer taking corticosteroids, and have been stable on imaging for ≥ 4 weeks following the last date of treatment are permitted.
- History of hypersensitivity to compounds of similar chemical or biologic composition to niraparib or its excipients.
- Participants must not be immunocompromised. Participants with prior splenectomy are allowed.
- Participants must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy.
- Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
- Participants must not have current evidence of any condition, therapy, or laboratory abnormality (including active or uncontrolled myelosuppression [ie, anemia, leukopenia, neutropenia, thrombocytopenia]) that might confound the results of the study or interfere with the participant's participation for the full duration of the study treatment or that makes it not in the best interest of the participant to participate.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or psychiatric illness/social situations that would limit compliance with study requirements.
- Known HIV-positive participants are ineligible because these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy.
- Participants with a clinically significant gastrointestinal disorder that in the opinion of the treating investigator could impact the absorption of the study drug, including but not limited to malabsorption syndrome or major resection of the stomach or bowels.
- Participants with a history of a clinically relevant second primary malignancy within the past 2 years. Exceptions include: resected basal and squamous cell carcinomas of the skin and completely resected carcinoma in situ of any type.
- Participants must not be on anticoagulant therapy unless the treating investigator has deemed it safe to temporarily hold to facilitate the collection of the pre-treatment tumor biopsy.
- Participant must not have received colony stimulating factors (eg, granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.
- Participant has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Phase 2 Proof-of-Concept Trial Testing the PARP Inhibitor Niraparib in Patients With Pancreatic Cancer Harboring Deficiencies in Homologous Recombination DNA Repair
This research study is studying an investigational therapy as a possible treatment for pancreatic cancer.
The drugs involved in this study are:
-Niraparib
Read the detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease.
The FDA (the U.S. Food and Drug Administration) has not approved niraparib for this specific disease but it has been approved for other uses.
Niraparib belongs to a class of anti-cancer agents known as PARP (poly ADP ribose polymerase) inhibitors. PARP is a protein in the body that repairs damage to DNA (one of the building blocks of a cell). In cells that are rapidly growing, such as cancer cells, blocking repair of DNA may be of benefit, since it will cause the cell to die.
In this research study, the investigators are looking to test the effectiveness of niraparib in patients with pancreatic cancer. The trial is focused on pancreatic cancer patients that have marker, a mutation in a DNA repair gene, suggesting that their cancer might be susceptible to niraparib.
- Conditions
- Pancreatic Cancer
- Being tested
- Niraparib
- Keywords
- Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiraparibDrug
Also called Zejula
Niraparib belongs to a class of anti-cancer agents known as PARP (poly ADP ribose polymerase) inhibitors. PARP is a protein in the body that repairs damage to DNA (one of the building blocks of a cell). In cells that are rapidly growing, such as cancer cells, blocking repair of DNA may be of benefit, since it will cause the cell to die.
Niraparib will be given at an initial dose of 200mg or 300 mg by mouth once daily depending on the patient's platelet count and weight at the start of the trial.
| Study group | Role | What they receive |
|---|---|---|
| Niraparib | Experimental | * Niraparib will be administered orally once daily
* Palliative radiation therapy to a small field >1 week prior to Day 1 of study treatment Receives: Drug: Niraparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Progression-free survival is defined as the time from registration to documented disease progression or death from any cause, whichever occurs first. Subjects who have not experienced an event of interest by the time of analysis will be censored at the date of the last disease assessment without progression.
Measured: 6 month
Secondary outcomes (3)
Overall response rate will be measured by RECIST criteria.
Measured: 2 years
Overall Survival Rate
Overall survival is defined as the time from registration to death from any cause, and subjects who are thought to be alive at the time of final analysis will be censored at the last date of contact.
Measured: 2 years
Evaluation of the safety and tolerability of niraparib as assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start22 Aug 2018
- Primary completion31 Dec 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Tesaro, Inc.
- Responsible party
- Principal investigator, James Cleary, MD, PhD, Dana-Farber Cancer Institute
- Investigators
- James Cleary, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601923
- Sponsor's protocol ID
- 18-207
- Status last verified
- Jan 2026
- First submitted
- 13 Jul 2018
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Proof-of-Concept Trial Testing the PARP Inhibitor Niraparib in Patients With Pancreatic Cancer Harboring Deficiencies in Homologous Recombination DNA Repair
- ClinicalTrials.gov ID
- NCT03601923
- Acronym / sponsor ID
- 18-207
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Tesaro, Inc.
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is studying an investigational therapy as a possible treatment for pancreatic cancer.
The drugs involved in this study are:
-Niraparib
Detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease.
The FDA (the U.S. Food and Drug Administration) has not approved niraparib for this specific disease but it has been approved for other uses.
Niraparib belongs to a class of anti-cancer agents known as PARP (poly ADP ribose polymerase) inhibitors. PARP is a protein in the body that repairs damage to DNA (one of the building blocks of a cell). In cells that are rapidly growing, such as cancer cells, blocking repair of DNA may be of benefit, since it will cause the cell to die.
In this research study, the investigators are looking to test the effectiveness of niraparib in patients with pancreatic cancer. The trial is focused on pancreatic cancer patients that have marker, a mutation in a DNA repair gene, suggesting that their cancer might be susceptible to niraparib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Niraparib | Experimental | Drug: Niraparib* Niraparib will be administered orally once daily * Palliative radiation therapy to a small field >1 week prior to Day 1 of study treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Participants must have a histologically confirmed advanced pancreatic adenocarcinoma that is not curable with standard approaches. Patients with metastatic pancreatic cancer and unresectable pancreatic cancer are eligible.
- Patients must have molecular characteristics that fulfill one of the following requirements:
- Patients must have received at least one line of treatment for their cancer prior to enrolling on the trial.
- Patients who had investigator assessed progression on an oxaliplatin-containing regimen (such as FOLFOX or FOLFIRINOX) are not eligible for the trial.
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
Key exclusion criteria (19 listed)
- Participants who have had cytotoxic chemotherapy, radiotherapy, immunotherapy, biologic therapy, or other investigational therapy within 2 weeks prior to entering the study or those who have not recovered to ≤ CTCAE (version 5.0) Grade 1 or baseline from adverse events due to agents administered more than 2 weeks earlier (with the exceptions of alopecia and peripheral neuropathy).
- Participants must not have received investigational therapy administered ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior initiating protocol therapy.
- Participants who have received oral targeted therapy or tyrosine kinase inhibitor (TKI) therapy within 5 half-lives or 2 weeks of study entry, whichever is shorter.
- Participants who have been previously treated with a PARP inhibitor.
- Participant has had radiation therapy encompassing >20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.
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 |
|---|---|---|
| NiraparibAlso: ZejulaNiraparib belongs to a class of anti-cancer agents known as PARP (poly ADP ribose polymerase) inhibitors. PARP is a protein in the body that repairs damage to DNA (one of the building blocks of a cell). In cells that are rapidly growing, such as cancer cells, blocking repair of DNA may be of benefit, since it will cause the cell to die. Niraparib will be given at an initial dose of 200mg or 300 mg by mouth once daily depending on the patient's platelet count and weight at the start of the trial. | Drug | Niraparib |
Primary outcome
Progression Free Survival
Time frame: 6 month
Progression-free survival is defined as the time from registration to documented disease progression or death from any cause, whichever occurs first. Subjects who have not experienced an event of interest by the time of analysis will be censored at the date of the last disease assessment without progression.
3 secondary outcomes
Overall response rate will be measured by RECIST criteria.
Time frame: 2 years
Overall Survival Rate
Time frame: 2 years
Evaluation of the safety and tolerability of niraparib as assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
James Cleary, MD, PhD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Niraparib in people with Pancreatic Cancer, run by Dana-Farber Cancer Institute at 3 sites 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 30 inclusion and 19 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: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression Free Survival (time frame: 6 month). 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 25 Mar 2026.