drugset / Trial / NCT02715804
A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA).
Timeline
- Start
- 2016-03-14
- Primary completion
- 2019-11-04
- Completion
- 2019-11-04
Outcome
Outcome not reported
Stopped (Business): “Sponsor decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 125 mg/m2 | Intravenous |
| Subject | PEGPH20 | Protein / enzyme biologic | 3 ug/kg | Intravenous |