Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors
Completed · Phase 1
Conditions studied: Solid Tumor
In brief
Open-label, multicenter, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study.
Key facts
- Study ID
- NCT00834704
- Run by
- Halozyme Therapeutics
- People needed
- 14
- Starts
- 2009-02-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2013-03-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- T Gen Clinical Research Services — Scottsdale, Arizona, United States
- Premiere Oncology — Santa Monica, California, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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