Clinical trialPhase 2Completed

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

A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma

NCT01124786 ↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome: Outcome unknown
Phase: Phase 2
Status: Completed
Study type: Interventional
Start: May 2010
Expected end: June 2013
Enrollment: 367 participants
Sites: 95
Primary outcomes: Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression
Sponsor: Industry
Results posted: 2014-04-17
Last update: 17 April 2014

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Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

Pancreatic cancer is a very serious form of cancer. The majority of patients present with unresectable disease, and the condition is often not diagnosed until the cancer is relatively advanced. The standard first-line treatment for patients with unresectable pancreatic cancer is gemcitabine monotherapy. Unfortunately many of these patients fail to derive benefit from this treatment. No clinical or molecular marker has been established to predict benefit from gemcitabine therapy, so patients are treated empirically until evidence of disease progression or worsening performance status. The potential for human equilibrative nucleoside transporter-1 (hENT1) expression to predict survival in gemcitabine-treated patients has been studied, and data suggest that patients with low levels of tumor cell hENT1 expression derive less benefit from gemcitabine treatment than patients with high levels of tumor cell hENT1 expression. These data support the hypothesis to be tested in this study that patients with pancreatic tumors expressing low levels of hENT1 will derive minimal benefit from gemcitabine, but will receive benefit from CO-1.01 (gemcitabine elaidate) which enters tumor cells in a hENT1-independent fashion.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression [Monthly follow up after treatment discontinuation until death, up to 1.5 years.]. Median, months (95% Confidence Interval). CO-1.01 (n=114): 5.7 (4.7 to 7.6); Gemcitabine (n=118): 6.1 (5.2 to 7.7). Analysis, CO-1.01 vs Gemcitabine: Hazard Ratio (HR) 0.994 (95% CI 0.746 to 1.326); p=<0.973; Log Rank; superiority or other.