At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 861 enrolled
Drug / intervention
Albumin-bound paclitaxel (ABI-007) +1 moredrug
Likely dose
Albumin-bound paclitaxel (ABI-007) 125 mgfrom 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 Randomized Phase III Study of Weekly ABI-007 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Adenocarcinoma of the Pancreas
In Brief
A Phase 3 clinical trial evaluating Albumin-bound paclitaxel (ABI-007) and Gemcitabine for Metastatic Pancreatic Cancer. Completed, enrolled 861 participants across 193 sites in 11 countries.
Detailed Summary
Phase III Metastatic Pancreatic Cancer
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Pancreatic Cancer
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Italy, Russia, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2009
Enrollment StartMar 2009
Primary CompletionSep 2012
Study CompletionApr 2013
TodayJul 2026
First PostedFeb 16, 2009
Enrollment StartMar 1, 2009
Primary CompletionSep 17, 2012
Study CompletionApr 9, 2013
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 17.4 years ago
Interventions
Albumin-bound paclitaxel (ABI-007)drug
ABI-007 125 mg/m\^2 administered by intravenous infusion
Gemcitabinedrug
Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).