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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01170897

Enrollment

Registered

2010-07-27

Start date

2010-07-31

Completion date

2014-01-31

Last updated

2014-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor

Keywords

PEGPH20, PEGylated Recombinant Human Hyaluronidase, Metastatic or Locally Advanced Solid Tumors

Brief 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.

Interventions

DRUGPEGPH20

PEGylated Recombinant Human Hyaluronidase

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Written, signed, IRB-approved informed consent form. * Pathologic (histologic or cytologic) confirmation of metastatic or locally advanced solid tumor. * Patients must have a pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available or the patient refuses standard therapy. * One or more tumors measurable by RECIST criteria. * Karnofsky performance status ≥ 70%. * Ejection fraction ≥ 50%, determined by echocardiogram. * Life expectancy at least 3 months. * Age ≥ 18 years. * Acceptable organ function; normal hepatic, renal and hematopoietic function. * Negative serum or urine pregnancy test result in women of childbearing potential.

Exclusion criteria

* Known brain metastasis. * New York Heart Association Class III or IV cardiac disease, myocardial infarction within 6 months of enrollment, or cardiac arrhythmia requiring medical therapy. * Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy. * Patients with uncontrolled diabetes (requiring medication change within 30 days of screening), or requiring insulin therapy. * Heparin therapy. * Known infection with HIV, hepatitis B, or hepatitis C. * Known allergy to hyaluronidase. * Women currently breast feeding.

Design outcomes

Primary

Measure	Time frame	Description
Maximally Tolerated Dose (MTD) of PEGPH20 when given to patients with cancer	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	The PEGPH20 monotherapy MTD is the highest dose at which no more than one of six evaluable patients experience Dose-Limiting Toxicity (DLT)
Safety endpoints including assessment of both serious and non-serious AEs	From Day 1 of Treatment Cycle 1, thru to Follow-up (within 28 days after last dose of PEGPH20)	All safety data will be evaluated using the NCI CTCAE scoring system (version 4.0)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026