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NCT01959139 · ClinicalTrials.gov registry record · Phase 1
S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer
A Phase 1 study, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 1
- Development phase
- 126
- Enrollment target
NCT01959139 is a Phase 1 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 126 participants.
The verdict
NCT01959139, a Phase 1 study, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 126 participants
- Enrollment target
Study Summary
This partially randomized phase I/II trial studies the side effects and best dose of pegylated recombinant human hyaluronidase (PEGPH20) when given together with combination chemotherapy and to see how well they work compared with combination chemotherapy alone in treating patients with newly diagnosed pancreatic cancer that has spread to other places in the body. Pegylated recombinant human hyaluronidase may help chemotherapy drugs work better by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination chemotherapy is more effective with or without pegylated recombinant human hyaluronidase in treating pancreatic cancer.
Interventions
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Irinotecan
- DRUG 5-fluorouracil
- DRUG PEGPH20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2014-01-23 |
| Est. Completion | 2023-11-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01959139
The ClinicalTrials.gov registry entry for NCT01959139 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 270 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Leucovorin is the first listed.
NCT01959139 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01959139 about?
NCT01959139 is a clinical study titled "S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer". This partially randomized phase I/II trial studies the side effects and best dose of pegylated recombinant human hyaluronidase (PEGPH20) when given together with combination chemotherapy and to see how well they work compared with combination chemotherapy alone in treating patients with newly diagno...
What is the current status of trial NCT01959139?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 126 participants. The study started on 2014-01-23. Estimated completion is 2023-11-09.
What interventions are being tested in trial NCT01959139?
The interventions under investigation include: Leucovorin (DRUG), Oxaliplatin (DRUG), Irinotecan (DRUG), 5-fluorouracil (DRUG), PEGPH20 (DRUG).
Who is sponsoring clinical trial NCT01959139?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
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