This is a single arm phase II trial assessing the potential activity of combination PEGPH20
plus Gemcitabine with radiotherapy in ten patients with localized, unresectable pancreatic
Drug: PEGylated Recombinant Human Hyaluronidase (PEGPH20)
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Locations near you
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Full eligibility criteria for NCT02910882
Ages eligible for Study
up to 90 Years
Genders eligible for Study
Accepts Healthy Volunteers
Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form;
For men and women of reproductive potential, agreement to use an effective contraceptive method from the time of screening and throughout their time on study. Effective contraceptive methods consist of prior sterilization, intra-uterine device, oral or injectable contraceptives, and/or barrier methods. Abstinence alone is not considered an adequate contraceptive measure for the purposes of this study;
Patients with previously untreated localized, unresectable histologically confirmed pancreatic adenocarcinoma (unresectable will be defined as locally advanced disease or when patients cannot have or refuse surgery);
Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L;
Platelets ≥ 100 x 109/L;
Hgb ≥ 9 g/dL;
Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 x [Upper Limit of Normal (ULN)];
Bilirubin ≤ 1.5 x ULN;
GFR ≥ 30 mL/min;
Patient has no clinically significant abnormalities in urinalysis results;
Patient has acceptable coagulation status as indicated by a Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) within 15% of normal limits;
Eastern Cooperative Oncology Group (ECOG) ≤ 2
Subjects are ineligible for enrollment if they meet any of the following exclusion criteria:
Clinical evidence of deep vein thrombosis (DVT), pulmonary embolism (PE) or other known thromboembolic (TE) event present during the screening period;
Any prior history of cerebrovascular accident, transient ischemic attack, or pre-existing carotid artery disease.
Known allergy to hyaluronidase;
Current use of megestrol acetate (use within 10 days of Day 1);
Contraindication to heparin including prior heparin induced thrombocytopenia (HIT), recent CNS bleed; intracranial or spinal lesion at high risk for bleeding; severe platelet dysfunction; recent major operation at high risk for bleeding; underlying hemorrhagic coagulopathy; high risk for falls; potential need for spinal anesthesia/lumbar puncture; active bleeding;
Women currently pregnant or breastfeeding;
Intolerance to dexamethasone;
Inability to comply with study and follow-up procedures as judged by the Investigator;
Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy;
Patient has known infection with HIV, hepatitis B, or hepatitis C;
Patient has a history of allergy or hypersensitivity to any of the agents they are supposed to receive (or to any of the excipients for those agents);
Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug, these can include New York Heart Association Functional Class ≥ 3, myocardial infarction within the past 12 months before screening, pre-existing atrial fibrillation, symptomatic COPD.
Patient is unwilling or unable to comply with study procedures.
All locations for NCT02910882
United States (1)
La Jolla, California, United States, 92037
View full eligibility
Tris trial is registered with FDA with number: NCT02910882. The sponsor of the trial is Scripps Health and it is looking for 4 volunteers for the current phase.
Official trial title: A Phase II Study Combining PEGPH20 With Concurrent Gemcitabine and Radiotherapy in Patients With Localized, Unresectable Pancreatic Adenocarcinoma
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