NCT01170897

Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors

A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Halozyme Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 either failed to respond to standard therapy or for whom no standard therapy exists.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	PEGPH20	PEGylated Recombinant Human Hyaluronidase

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-10-01
• Completion: 2014-01-01
• First posted: 2010-07-27
• Last updated: 2014-01-29

Locations

5 sites across 1 country: United States