drugset
drugset / Trial / NCT01124786

A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)

NCT01124786 ↗

Phase 2 Completed 367 enrolled Clovis Oncology, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine.

Timeline

Start
2010-05
Primary completion
2012-11
Completion
2013-06

Outcome

Missed primary endpoint

registry Hazard Ratio (HR) 0.994 (95% CI 0.746 to 1.326); Log Rank NCT01124786 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject gemcitabine elaidate Small molecule 1250 mg/m2 Intravenous

Indications

pancreatic adenocarcinoma