Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Halozyme Therapeutics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed Informed consent.
Histologically confirmed Stage IV PDA with documented disseminated neoplasm to liver and /or lung. Must have archival or fresh tissue (block /slides) available pre-dose.
One or more metastatic tumors measurable on computed tomography (CT) scan per RECIST v.1.1 , excluding the primary pancreatic lesion.
No previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
Karnofsky Performance Status greater than or equal to (≥) 70%.
Life expectancy ≥3 months.
Age ≥18 years.
Screening laboratory values of hemoglobin, platelets, absolute neutrophil count (ANC), bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), serum creatinine, serum albumin, prothrombin time/international normalized ratio (INR), and partial thromboplastin time (PTT) within specified values/criteria per protocol prior to dosing.
You may not be if
Non-metastatic PDA.
Evidence of deep vein thrombosis (DVT), pulmonary embolism (PE), or other known thromboembolic event present during screening period.
Known central nervous system involvement or brain metastasis.
New York (NY) Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months.
Prior history of cerebrovascular accident or transient ischemic attack.
Pre-existing carotid artery disease.
Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
Current use of megestrol acetate (use within 10 days of Day 1).
Known infection with human immunodeficiency virus, Hepatitis B, or Hepatitis C.
History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early state prostate cancer, or curatively-treated cervical cancer in-situ.
Contraindication to heparin as per National Comprehensive Cancer Network (NCCN) guidelines.
Previous major bleed (bleeding requiring transfusion of red blood cells) on low-molecular weight heparin (LMWH).
Any other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of disease or condition that contraindicates the use of an investigational drug, that may affect interpretation of results, or render the participant at a high risk of treatment complications.
Clareo Health | PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Participants With Stage IV Untreated Pancreatic Cancer
