Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-01-31

Brief Summary

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This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study in patients with advanced solid tumors.

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Detailed Description

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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.

Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Maximally Tolerated Dose

To identify the maximally tolerated dose (MTD) of PEGPH20.

Group Type OTHER

PEGPH20

Intervention Type DRUG

PEGylated Recombinant Human Hyaluronidase

Interventions

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PEGPH20

PEGylated Recombinant Human Hyaluronidase

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No