Completed
PHASE3
INTERVENTIONAL
NCT01964430
Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Detailed Description
ABI-007-PANC-003 is a Phase 3, international, multicenter, randomized, open-label, controlled study that will compare the efficacy of nab-paclitaxel in combination with gemcitabine to gemcitabine alone as adjuvant treatment for 6 cycles in patients with surgically resected pancreatic adenocarcinoma.
Interventions
Name:
nab-Paclitaxel
Type:
DRUG
Description:
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.
Name:
Gemcitabine
Type:
DRUG
Description:
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.
Primary Outcomes
Measure:
Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee
TimeFrame:
Date of randomization up to data cut off date of 31 December 2018; median DFS follow-up time for censored participants was 22.242 months for nab-Paclitaxel and gemcitabine and 13.832 months for gemcitabine alone
Description:
Disease free survival was defined as the time from the date of randomization to the date of disease recurrence or death, whichever occurred earlier. Disease recurrence was determined by the independent radiological review of computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants who did not have disease recurrence or did not die were censored at the last tumor assessment date with disease-free status or the randomization date if the last tumor assessment with disease-free status was missing. Disease-free status referred to a status that was neither being disease recurrent nor indeterminate or not evaluable. Participants who received new anti-cancer therapy or cancer-related surgery prior to disease recurrence or death were censored at the date of last tumor assessment with disease-free status prior to the start of new anti-cancer therapy or cancer-related surgery or the randomization date.
Trial Information
NCT ID
NCT01964430
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Celgene
Last Updated
December 15, 2025