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
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Maximally Tolerated Dose (MTD) of PEGPH20 when given to patients with cancer
The PEGPH20 monotherapy MTD is the highest dose at which no more than one of six evaluable patients experience Dose-Limiting Toxicity (DLT)
To be evaluable for MTD determination, a patient must have completed the Cycle 1 study drug doses and the associated assessments for safety and toxicity evaluation
Yes
Joy Zhu, M.D.
Study Director
Halozyme Therapeutics
United States: Food and Drug Administration
HALO-109-102
NCT01170897
July 2010
June 2013
Name | Location |
---|---|
Karmanos Cancer Institute | Detroit, Michigan 48201 |
Mayo Clinic - Scottsdale | Scottsdale, Arizona 85259 |
Ramesh K. Ramanathan M.D. | Scottsdale, Arizona 85258 |
cCare - California Cancer Associatesfor Research Excellence | Encinitas, California 92024 |
Jeffrey R. Infante | Nashville, Tennessee 37203 |