Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Solid Tumor
In brief
This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study in patients with advanced solid tumors.
Key facts
- Study ID
- NCT01170897
- Run by
- Halozyme Therapeutics
- People needed
- 27
- Starts
- 2010-07-01
- Expected to finish
- 2014-01-01
- Last updated by the study team
- 2014-01-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Written, signed, IRB-approved informed consent form.
- 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 qualify 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.
Where it is running
- Ramesh K. Ramanathan M.D. — Scottsdale, Arizona, United States
- Mayo Clinic - Scottsdale — Scottsdale, Arizona, United States
- cCare - California Cancer Associatesfor Research Excellence — Encinitas, California, United States
- Karmanos Cancer Institute — Detroit, Michigan, United States
- Jeffrey R. Infante — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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