Status:
COMPLETED
Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors
Lead Sponsor:
Halozyme Therapeutics
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study in patients with advanced solid tumors.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01170897
Start Date
July 1 2010
End Date
January 1 2014
Last Update
January 29 2014
Active Locations (5)
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1
Ramesh K. Ramanathan M.D.
Scottsdale, Arizona, United States, 85258
2
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States, 85259
3
cCare - California Cancer Associatesfor Research Excellence
Encinitas, California, United States, 92024
4
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201