Niraparib in Patients With Pancreatic Cancer

NCT03601923 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 18-207
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

This research study is studying an investigational therapy as a possible treatment for pancreatic cancer. The drugs involved in this study are:

• Niraparib

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  6 month

Secondary Outcomes (3)

• Overall response rate will be measured by RECIST criteria.

  2 years

• Overall Survival Rate

  2 years

• Evaluation of the safety and tolerability of niraparib as assessed by the Common Terminology Criteria for Adverse Events (CTCAE)

  2 years

Study Arms (1)

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

Drug: Niraparib

Interventions

Niraparib DRUG

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.

Also known as: Zejula

Niraparib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Tesaro, Inc.: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

niraparib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• James Cleary, MD, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: July 26, 2018
• Study Start: August 22, 2018
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)