At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 367 enrolled
Drug / intervention
CO-1.01 +1 moredrug
Likely dose
CO-1.01 1250 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma
In Brief
A Phase 2 clinical trial evaluating CO-1.01 and Gemcitabine for Metastatic Pancreatic Adenocarcinoma. Completed, enrolled 367 participants across 95 sites in 15 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Pancreatic Adenocarcinoma
CountriesArgentina, Australia, Belgium, Brazil, Canada, France, Germany, Italy, Netherlands, Norway, Russia, Sweden, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2010
First PostedMay 2010
Primary CompletionNov 2012
Study CompletionJun 2013
TodayJul 2026
First PostedMay 17, 2010
Enrollment StartMay 1, 2010
Primary CompletionNov 1, 2012
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.1 years ago
Interventions
CO-1.01drug
1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
Gemcitabinedrug
1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks