Trials / Terminated
TerminatedNCT02715804
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
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Subjects With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 492 (actual)
- Sponsor
- Halozyme Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
Participants will be randomized in a 2:1 ratio to PAG or AG treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20) | PEGPH20 will be administered as per the dose and schedule specified in the respective arms. |
| DRUG | Placebo | Matching placebo for PEGPH20 |
| DRUG | nab-Paclitaxel | Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms. |
| DRUG | Gemcitabine | Gemcitabine will be administered as per the dose and schedule specified in the respective arms. |
Timeline
- Start date
- 2016-03-14
- Primary completion
- 2019-11-04
- Completion
- 2019-11-04
- First posted
- 2016-03-22
- Last updated
- 2020-07-14
- Results posted
- 2020-07-14
Locations
217 sites across 22 countries: United States, Australia, Belgium, Brazil, Canada, Croatia, Czechia, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Netherlands, Poland, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02715804. Inclusion in this directory is not an endorsement.