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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: Completed Phase 1 study, sponsored by SWOG Cancer Research Network.
NCT01959139 is a Phase 1 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 126 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (110% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assess safety of mFOLFIRINOX in combination with PEGPH20 and select the optimal dose of PEGPH20 for the Phase II portion. MTD of PEGPH20 in combination with mFOLFORINOX was evaluated by testing decreasing doses of PEGPH20 from 3mcg/kg on Day 1 and Day 3/4, to 3mcg/kg on Day 1 only and to 1.6 mcg/kg on Day 1 only. MTD reflects the highest dose that had a dose-limiting toxicity (DLT) rate of ≤ 17%. DLTs were defined as treatment regimen related: grade ≥ 3 non-hematologic toxicity; grade 4 absolu
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 |
What the finished NCT01959139 record still lists
NCT01959139 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (110% higher).
The record links to 0 conditions, and to 5 interventions - of which Leucovorin is the first listed.
NCT01959139 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01959139's enrollment target sits among peer trials
126 461st of 2000 higher than 1,534 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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