NCT00834704

Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors

Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Given Intravenously to Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Halozyme Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 patients will receive a higher dose than the previous group. This will continue until the group with the highest planned dose completes the study or until a group has major side effects from their assigned dose.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	PEGPH20	PEGylated recombinant human hyaluronidase

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-06-01
• Completion: 2012-11-01
• First posted: 2009-02-03
• Last updated: 2013-03-26

Locations

3 sites across 1 country: United States