Trials / Completed
CompletedNCT02993731
A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
A Phase III Study of BBI-608 Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,134 (actual)
- Sponsor
- Sumitomo Pharma America, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, open-label, multi-center, phase 3 study of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine for adult patients with Metastatic Pancreatic Ductal Adenocarcinoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Napabucasin | Napabucasin will be administered orally, twice daily, with doses separated by approximately 12 hours. |
| DRUG | Nab-paclitaxel | Nab-paclitaxel 125 mg/m\^2 immediately followed by gemcitabine 1000 mg/m\^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion. |
| DRUG | Gemcitabine | Nab-paclitaxel 125 mg/m\^2 immediately followed by gemcitabine 1000 mg/m\^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion. |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2020-03-01
- Completion
- 2020-03-01
- First posted
- 2016-12-15
- Last updated
- 2023-11-15
- Results posted
- 2021-06-10
Locations
267 sites across 20 countries: United States, Australia, Austria, Belgium, Canada, China, Czechia, France, Germany, Italy, Japan, Netherlands, Poland, Portugal, Russia, Singapore, South Korea, Spain, Taiwan, Ukraine
Source: ClinicalTrials.gov record NCT02993731. Inclusion in this directory is not an endorsement.