Status:
COMPLETED
Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors
Lead Sponsor:
Halozyme Therapeutics
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Open-label, multicenter, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study.
Detailed Description
This is a study of PEGPH20 in human subjects and is designed to evaluate the safety of PEGPH20 and to determine the maximum tolerated dose of PEGPH20. All patients will receive PEGPH20. Each group of ...
Eligibility Criteria
Inclusion
- Pathologic (histologic or cytologic) confirmation of metastatic or locally advanced solid tumor.
- Patients who have experienced disease progression after receiving appropriate standard / approved chemotherapy and for whom no further standard or palliative treatment measures exist, or who have chosen to decline standard or palliative treatment.
- One or more tumors measurable by RECIST criteria.
- Karnofsky performance status ≥ 70%.
- Recovery from any toxic or other effects of all previous therapy, including radiation, chemotherapy and surgery.
- Negative serum or urine pregnancy test result in women of childbearing potential.
- For men and women of child-producing potential, agreement to use effective contraception (hormonal or barrier birth control or abstinence) from the time of screening before study entry and throughout study participation.
Exclusion
- Brain metastasis.
- New York Heart Association Class III or IV cardiac disease, myocardial infarction, or cardiac arrhythmia requiring medical therapy.
- Known allergy to hyaluronidase.
- Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions including psychiatric illness) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
- Women currently breast feeding.
- Concurrent participation in any other interventional therapeutic study.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00834704
Start Date
February 1 2009
End Date
November 1 2012
Last Update
March 26 2013
Active Locations (3)
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1
T Gen Clinical Research Services
Scottsdale, Arizona, United States, 85258
2
Premiere Oncology
Santa Monica, California, United States, 90404
3
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203