Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Open-label, multicenter, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Halozyme Therapeutics

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.