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Lead
Halozyme Therapeutics
A study of PEGylated recombinant human hyaluronidase (PEGPH20) administered on a twice weekly schedule for 28 days followed by a weekly dosing schedule in patients with advanced solid tumors who have either failed to respond to standard therapy or for whom no standard therapy exists.
Pathologic (histologic or cytologic) confirmation of metastatic or locally advanced solid tumor.
Patients must have a pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available or the patient refuses standard therapy.
One or more tumors measurable by RECIST criteria.
Karnofsky performance status ≥ 70%.
Ejection fraction ≥ 50%, determined by echocardiogram.
Life expectancy at least 3 months.
Age ≥ 18 years.
Acceptable organ function; normal hepatic, renal and hematopoietic function.
Negative serum or urine pregnancy test result in women of childbearing potential.
You may not be if
Known brain metastasis.
New York Heart Association Class III or IV cardiac disease, myocardial infarction within 6 months of enrollment, or cardiac arrhythmia requiring medical therapy.
Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
Patients with uncontrolled diabetes (requiring medication change within 30 days of screening), or requiring insulin therapy.
Heparin therapy.
Known infection with HIV, hepatitis B, or hepatitis C.
Known allergy to hyaluronidase.
Women currently breast feeding.
Clareo Health | Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors
