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Open-label, multicenter, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Dose determination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEGPH20 | Drug | PEGylated recombinant human hyaluronidase |
|
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joy Zhu, M.D. | Halozyme Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| T Gen Clinical Research Services | Scottsdale | Arizona | 85258 | United States | ||
| Premiere Oncology |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000632509 | PEGPH20 |
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| 28 days |
| To explore pharmacodynamic endpoints that may guide the further development of PEGPH20. | 28 days |
| Santa Monica |
| California |
| 90404 |
| United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |