At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 89 enrolled
Drug / intervention
BI 2536drug
Likely dose
Not stated in 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.
An Open, Randomised, Clinical Phase II Trial in Patients With Unresectable Advanced Pancreatic Cancer Investigating the Efficacy, Safety, and Pharmacokinetics of BI 2536 Administered in Repeated 3-week Cycles as a Single i.v. Dose of 200 mg on Day 1 or as 60 mg Doses on Days 1, 2, and 3
In Brief
A Phase 2 clinical trial evaluating BI 2536 for Pancreatic Neoplasms. Completed, enrolled 89 participants across 10 sites in 2 countries.
Detailed Summary
The trial is conducted in order to evaluate the efficacy, safety and pharmacokinetics of BI 2536 in the treatment of unresectable advanced pancreatic cancer as first line or second line therapy. A secondary aim is to identify the most suitable dosage regimen for the further phase II and III clinical programme of BI 2536. To achieve this objective, two dosage regimens are compared in patients receiving first line therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Neoplasms
CountriesAustria, Germany
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2006
First PostedJul 2008
Primary CompletionOct 2008
TodayJul 2026
First PostedJul 4, 2008
Enrollment StartAug 1, 2006
Primary CompletionOct 14, 2008
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 18.0 years ago
Interventions
BI 2536drug
Intravenous Infusion