Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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Open-label, multicenter, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study.

Detailed Description
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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.

Official Title
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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

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: PEGPH20


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Dose determination | Drug: PEGPH20<br>* PEGylated recombinant human hyaluronidase<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the pharmacokinetics (PK) of PEGPH20 |  | 28 days | 
| To determine the dose-limiting toxicities (DLTs) of PEGPH20. |  | 28 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEGPH20, PEGylated recombinant human hyaluronidase, Metastatic or locally advanced solid tumor