Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors
Study Details
Study Description
Brief Summary
This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study in patients with advanced solid tumors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Maximally Tolerated Dose To identify the maximally tolerated dose (MTD) of PEGPH20. |
Drug: PEGPH20
PEGylated Recombinant Human Hyaluronidase
|
Outcome Measures
Primary Outcome Measures
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Written, signed, IRB-approved informed consent form.
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Pathologic (histologic or cytologic) confirmation of metastatic or locally advanced solid tumor.
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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.
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One or more tumors measurable by RECIST criteria.
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Karnofsky performance status ≥ 70%.
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Ejection fraction ≥ 50%, determined by echocardiogram.
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Life expectancy at least 3 months.
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Age ≥ 18 years.
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Acceptable organ function; normal hepatic, renal and hematopoietic function.
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Negative serum or urine pregnancy test result in women of childbearing potential.
Exclusion Criteria:
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Known brain metastasis.
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New York Heart Association Class III or IV cardiac disease, myocardial infarction within 6 months of enrollment, or cardiac arrhythmia requiring medical therapy.
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Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
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Patients with uncontrolled diabetes (requiring medication change within 30 days of screening), or requiring insulin therapy.
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Heparin therapy.
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Known infection with HIV, hepatitis B, or hepatitis C.
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Known allergy to hyaluronidase.
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Women currently breast feeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ramesh K. Ramanathan M.D. | Scottsdale | Arizona | United States | 85258 |
| 2 | Mayo Clinic - Scottsdale | Scottsdale | Arizona | United States | 85259 |
| 3 | cCare - California Cancer Associatesfor Research Excellence | Encinitas | California | United States | 92024 |
| 4 | Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 5 | Jeffrey R. Infante | Nashville | Tennessee | United States | 37203 |
Sponsors and Collaborators
- Halozyme Therapeutics
Investigators
- Study Director: Joy Zhu, M.D., Halozyme Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HALO-109-102