This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study in 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
27
PEGylated Recombinant Human Hyaluronidase
Ramesh K. Ramanathan M.D.
Scottsdale, Arizona, United States
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States
cCare - California Cancer Associatesfor Research Excellence
Encinitas, California, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
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)
Time frame: 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
Safety endpoints including assessment of both serious and non-serious AEs
All safety data will be evaluated using the NCI CTCAE scoring system (version 4.0)
Time frame: From Day 1 of Treatment Cycle 1, thru to Follow-up (within 28 days after last dose of PEGPH20)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Jeffrey R. Infante
Nashville, Tennessee, United States