Clinical trial NCT00834704: Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Keywords: PEGPH20
PEGylated recombinant human hyaluronidase
Metastatic or locally advanced solid tumor
Lead sponsor: Halozyme Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-02-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 28 days
Secondary outcomes:
measure: To determine the pharmacokinetics (PK) of PEGPH20
timeFrame: 28 days
measure: To determine the dose-limiting toxicities (DLTs) of PEGPH20.
timeFrame: 28 days
measure: To observe patients for any evidence of anti-tumor activity (efficacy).
timeFrame: 28 days
measure: To explore pharmacodynamic endpoints that may guide the further development of PEGPH20.
timeFrame: 28 days
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: T Gen Clinical Research Services
state: Arizona
city: Santa Monica
country: United States
facility: Premiere Oncology
state: California
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
Study officials:
affiliation: Halozyme Therapeutics
name: Joy Zhu, M.D.
role: STUDY_DIRECTOR
References: