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| ID | Type | Description | Link |
|---|---|---|---|
| IRB833642 | Other Identifier | Abramson Cancer Center |
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Halozyme halted development of PEGPH20 following Phase 3 failure.
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| Name | Class |
|---|---|
| Halozyme Therapeutics | INDUSTRY |
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This research study is being conducted to determine the effects of PEGPH20 plus chemotherapy treatment on the MRI characteristics of locally advanced pancreatic cancer patient tumors. Subjects will received Gemcitabine, Abraxane and PEGPH20.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegvorhyaluronidase alfa plus Abraxane and Gemcitabine | Experimental | Pegvorhyaluronidase alfa 3ug/kg IV twice weekly during Cycle 1 and then weekly on days of chemotherapy during Cycles 2-4. Abraxane 125mg/m2 IV and Gemcitabine 1000mg/m2 IV on Day 1, 8, 15 of Cycles 1-4. All cycles will be 28 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegvorhyaluronidase alfa | Drug | IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in lesion size | Change in lesion size | baseline and 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving a complete R0 surgical resection | Proportion of patients achieving a complete R0 surgical resection | at time of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Karasic, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center at University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| C000632509 | PEGPH20 |
| D000068196 | Albumin-Bound Paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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| Abraxane | Drug | IV infusion |
|
| Gemcitabine | Drug | IV infusion |
|
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |