Clinical trial NCT01170897: Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Keywords: PEGPH20
PEGylated Recombinant Human Hyaluronidase
Metastatic or Locally Advanced Solid Tumors
Lead sponsor: Halozyme Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-07-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximally Tolerated Dose (MTD) of PEGPH20 when given to patients with cancer
timeFrame: 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
measure: Safety endpoints including assessment of both serious and non-serious AEs
timeFrame: From Day 1 of Treatment Cycle 1, thru to Follow-up (within 28 days after last dose of PEGPH20)
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Ramesh K. Ramanathan M.D.
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic - Scottsdale
state: Arizona
city: Encinitas
country: United States
facility: cCare - California Cancer Associatesfor Research Excellence
state: California
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Nashville
country: United States
facility: Jeffrey R. Infante
state: Tennessee
Study officials:
affiliation: Halozyme Therapeutics
name: Joy Zhu, M.D.
role: STUDY_DIRECTOR
References: