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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00834704

Acronym

PEG

Enrollment

Registered

2009-02-03

Start date

2009-02-28

Completion date

2012-11-30

Last updated

2013-03-26

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 tumor

Brief 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.

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

* Pathologic (histologic or cytologic) confirmation of metastatic or locally advanced solid tumor. * Patients who have experienced disease progression after receiving appropriate standard / approved chemotherapy and for whom no further standard or palliative treatment measures exist, or who have chosen to decline standard or palliative treatment. * One or more tumors measurable by RECIST criteria. * Karnofsky performance status ≥ 70%. * Recovery from any toxic or other effects of all previous therapy, including radiation, chemotherapy and surgery. * Negative serum or urine pregnancy test result in women of childbearing potential. * For men and women of child-producing potential, agreement to use effective contraception (hormonal or barrier birth control or abstinence) from the time of screening before study entry and throughout study participation.

Exclusion criteria

* Brain metastasis. * New York Heart Association Class III or IV cardiac disease, myocardial infarction, or cardiac arrhythmia requiring medical therapy. * Known allergy to hyaluronidase. * Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions including psychiatric illness) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor. * Women currently breast feeding. * Concurrent participation in any other interventional therapeutic study.

Design outcomes

Primary

Measure	Time frame
To determine the recommended phase 2 dose (RP2D) of PEGPH20. To evaluate the safety and tolerability of PEGPH20 in advanced cancer patients over a range of doses.	28 days

Secondary

Measure	Time frame
To observe patients for any evidence of anti-tumor activity (efficacy).	28 days
To explore pharmacodynamic endpoints that may guide the further development of PEGPH20.	28 days
To determine the pharmacokinetics (PK) of PEGPH20	28 days
To determine the dose-limiting toxicities (DLTs) of PEGPH20.	28 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026