drugset / Trial / NCT03807999

Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine For The First Line Treatment of Pancreas Cancer

NCT03807999 ↗

Phase 2 Completed 125 enrolled Hacettepe University Celgene Corporation · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, multicenter, phase II study of with nab-paclitaxel plus gemcitabine or gemcitabine alone for the treatment of chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer. Arm 1: Nab-paclitaxel plus gemcitabine Arm 2: Gemcitabine alone

Timeline

Start
2015-02-19
Primary completion
2018-04-01
Completion
2018-11-01

Outcome

Met primary endpoint

paper Overall QoL analyses showed that 34 and 58.3% of cases in gemcitabine and gemcitabine+nab-P arms had no deterioration in 3rd month QoL scores (p = 0.018). PMID 32228512 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 1000 mg/m2 —
Comparator Nab-paclitaxel Small molecule 125 mg/m2 —

Indications