CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,134 enrolled
Drug / intervention
Napabucasin +2 moredrug
Likely dose
Nab-paclitaxel 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02993731
NCT02993731Phase 3Completed
CompareCT.gov

A Phase III Study of BBI-608 Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma

Sumitomo Pharma America, Inc.·interventional·Posted Dec 15, 2016·Updated Nov 15, 2023

In Brief

A Phase 3 clinical trial evaluating Napabucasin, Nab-paclitaxel, and 1 other intervention for Carcinoma, Pancreatic Ductal. Completed, enrolled 1,134 participants across 267 sites in 20 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Pancreatic Ductal
CountriesAustralia, Austria, Belgium, Canada, China, Czechia, France, Germany, Italy, Japan, Netherlands, Poland, Portugal, Russia, Singapore, South Korea, Spain, Taiwan, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 15, 2016
Enrollment StartDec 1, 2016
Primary CompletionMar 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 9.5 years ago

Interventions

Napabucasindrug

Napabucasin will be administered orally, twice daily, with doses separated by approximately 12 hours.

Nab-paclitaxeldrug

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.

Gemcitabinedrug

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.