Niraparib in Patients With Pancreatic Cancer

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Brief Title

Niraparib in Patients With Pancreatic Cancer

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

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
    

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Progression Free Survival

Secondary Outcome

 Overall response rate will be measured by RECIST criteria.

Condition

Pancreatic Cancer

Intervention

Niraparib

Study Arms / Comparison Groups

 Niraparib
Description:  Niraparib will be administered orally once daily
Palliative radiation therapy to a small field >1 week prior to Day 1 of study treatment

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

32

Start Date

August 22, 2018

Completion Date

February 28, 2025

Primary Completion Date

February 28, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  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)

               -  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.

        Exclusion Criteria:

          -  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.

          -  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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

James Cleary, MD, PhD, 617-632-5960, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03601923

Organization ID

18-207


Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Collaborators

 Tesaro, Inc.

Study Sponsor

James Cleary, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute


Verification Date

July 2019