Trial intelligence / Profile preview

CO-1.01 in Gemcitabine-Refractory Pancreatic Cancer

NCT01233375Phase 2

Key facts

Status: Completed
Start: Apr 2011
Primary completion: Mar 2013
Countries: 1
Sponsor: Clovis Oncology
Modality: Prodrugs/Conditional Activator Small Molecules

Drugs: gemcitabine elaidate
Conditions: pancreatic adenocarcinoma (PDAC)

Overview

Phase 2, open-label, single-arm trial of gemcitabine elaidate in pancreatic adenocarcinoma (PDAC), sponsored by Clovis Oncology. Primary endpoint: Disease Control Rate. Started Apr 2011; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

CO-1.01
CO-1.01 monotherapy

Who it enrols

Patients with gemcitabine-refractory metastatic pancreatic adenocarcinoma and no tumor hENT1 expression.

Endpoints

Primary

Disease Control RateEvery 8 weeks

Secondary

Overall Response RateEvery 8 weeks
CA 19-9 response rateEvery 4 weeks
Progression-free survivalEvery 8 weeks
Number of Participants with Adverse EventsEvery week
Overall survival12 months
Median progression-free survival12 months
Median overall survival12 months
Duration of responseEvery 8 weeks

Beyond the preview

Go deeper on NCT01233375.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT01233375.