drugset / Trial / NCT01453153
Study of Gemcitabine + PEGPH20 vs Gemcitabine Alone in Stage IV Previously Untreated Pancreatic Cancer
RandomizedParallel-groupDouble-blindTreatment
Summary
Phase 1B: Open label (all patients receive PEGPH20+gemcitabine), dose escalation, safety and tolerability study to determine the safe dose of PEGPH20 to use in combination with gemcitabine in Stage IV previously untreated pancreatic cancer patients. Phase 2: Randomized, double blind study to compare the effect of overall survival of gemcitabine plus PEGPH20 vs gemcitabine plus placebo in Stage IV previously untreated pancreatic cancer patients.
Timeline
- Start
- 2011-09
- Primary completion
- 2014-02
- Completion
- 2015-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegvorhyaluronidase Alfa | Protein / enzyme biologic | 1 ug/kg | — |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |