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Nab-paclitaxel + Gemcitabine in Fragile Advanced Pancreatic Cancer

NCT02382263Phase 2

Key facts

Status: Completed
Start: Apr 2013
Primary completion: Apr 2016
Countries: 1
Modality: Small Molecules

Drugs: paclitaxel

Overview

Phase 2, randomised, open-label trial of paclitaxel (4 arms). Primary endpoints: Therapeutic Index of Combination at 2 months and Overall Survival at 6 months. Started Apr 2013; status: completed.

Design

4 arms

Study design: RandomizedOpen-label

Arm B
Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 weeks 1,3/4
Arm C
Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4
Arm D
Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,3/4
Arm E
Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4

Who it enrols

Adult patients with histologically confirmed metastatic pancreatic adenocarcinoma and ECOG performance status of 2. Patients must have adequate organ function and no prior chemotherapy for advanced disease.

Endpoints

Primary

Therapeutic Index of Combination2 months
Overall Survival6 months

Secondary

Safety Profile6 months
Objective Response Rate6 months
Progression Free Survival8 months
Tumor Marker CA19.9 Change8 months
FAP and Cav-1 Tumor Markers Change6 months

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