CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 866 enrolled
Drug / intervention
nab-Paclitaxel +1 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/NCT01964430
NCT01964430Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Open-label, Randomized Study of Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma

Celgene·interventional·Posted Oct 17, 2013·Updated Jun 28, 2023

In Brief

A Phase 3 clinical trial evaluating nab-Paclitaxel and Gemcitabine for Pancreatic Neoplasms and 9 related conditions. Completed, enrolled 866 participants across 341 sites in 21 countries.

Detailed Summary

The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in participants with surgically removed pancreatic cancer who then take nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Endocrine Gland Neoplasms, Pancreatic Diseases, Digestive System Diseases, Endocrine System Diseases, Gemcitabine, Antimetabolites, Antineoplastic
CountriesAustralia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Italy, Netherlands, Portugal, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 17, 2013
Enrollment StartMar 28, 2014
Primary CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 12.7 years ago

Interventions

nab-Paclitaxeldrug

nab-Paclitaxel 125 mg/m\^2 on Days 1, 8, and 15 of every 28 day treatment cycle by intravenous (IV) administration for a total of 6 cycles.

Gemcitabinedrug

Gemcitabine 1000 mg/m\^2 on Days 1, 8, and 15 of a 28 day cycle by IV administration for a total of 6 cycles.