New enzyme combo aims to break down pancreatic tumors
NCT ID NCT02921022
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding an experimental drug called PEGPH20 to standard chemotherapy can help shrink advanced pancreatic cancer. PEGPH20 breaks down hyaluronan, a substance that builds up in pancreatic tumors and may help them grow. The trial includes 110 people with advanced pancreatic cancer that cannot be removed by surgery. Researchers are also watching for side effects, especially blood clots.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Oct 2016
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Signed, written Institutional Review Board (IRB)-approved Informed Consent Form (ICF). * Histologically confirmed locally advanced unresectable (Stage III) or Stage IV PDAC. * Measurable or evaluable disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST v1.1. * For patients with locally advanced disease, no previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of PDAC is permitted. For patients with metastatic disease, prior treatment for non-metastatic disease with 5-FU or gemictabine administered as radiation sensitizer, or as a cytotoxic therapy, in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no ≥ Grade 2 treatment-related toxicities are present. * Karnofsky Performance Status ≥70%. * Life expectancy ≥3 months. * Age ≥18 years. * A negative serum pregnancy test, if female of reproductive potential. * Screening clinical laboratory values as follows, performed within 14 days prior to day 1: * Total bilirubin ≤1.5 times upper limit of normal (ULN). * Aspartate aminotransferase (\[AST\]; serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (\[ALT\]; serum glutamic pyruvate transaminase \[SGPT\]) ≤2.5 times ULN, (if liver metastases are present, then ≤5 times ULN is allowed). * Serum creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥60 mL/min. * Serum albumin ≥3.0 g/dL. * Absolute neutrophil count (ANC) ≥1,500 cells/mm3. * Platelet count ≥100,000 plt/mm3. * Hemoglobin ≥9 g/dL * Prothrombin time (PT)/international normalized ratio (INR) within normal limits (±15%) or within therapeutic range if on warfarin. * Partial thromboplastin time (PTT) within normal limits (±15%). * 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. Exclusion Criteria: * Known central nervous system involvement or brain metastases. * New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months. * Known, clinically significant carotid artery disease. * Known, increased risk of bleeding. * Patients with TE event occurring \> 6months prior to enrollment and receiving active anticoagulation. * Patients with any prior history of arterial thrombosis or symptomatic pulmonary embolism. * Patients with current use of megestrol acetate (use with 10 days of Day 1) will be excluded. * Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy. * Known active infection with human immunodeficiency virus, hepatitis B, or hepatitis C. * Known allergy to hyaluronidase. * Patients with prosthetic heart valves * Women currently pregnant or breastfeeding. * Intolerance of dexamethasone. * History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer or curatively-treated cervical carcinoma in-situ. * History of transient ischemic attack (TIA) or cerebrovascular accident (CVA). * Any other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that may render the subject at high risk for treatment complications. * Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for the study. * Inability to comply with study and follow-up procedures as judged by the Investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, 06102, United States
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Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
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Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
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Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
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Miami Cancer Institute
Miami, Florida, 33143, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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