At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Romidepsin +1 moredrug
Likely dose
Romidepsin 12 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 Phase I/II Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors.
In Brief
A Phase 1 clinical trial evaluating Romidepsin and Gemcitabine for Pancreatic Cancer. Completed, enrolled 36 participants across 1 site.
Detailed Summary
This was a phase I dose escalation trial designed to determine the maximum tolerated dose (MTD) for the combination of romidepsin (depsipeptide) and gemcitabine. The study was originally planned as a Phase I/II; however only Phase I of the study was conducted.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
First PostedSep 2006
Primary CompletionJul 2008
TodayJul 2026
First PostedSep 22, 2006
Enrollment StartJul 1, 2006
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 19.8 years ago
Interventions
Romidepsindrug
7, 10 or 12 mg/m\^2 via intravenous infusion over 4 hours on either Days 1, 8 and 15 or Days 1 and 15 of each 28-day cycle.
Gemcitabinedrug
800 or 1000 mg/m\^2 via intravenous infusion over 30 minutes on either Days 1,8 and 15 or Days 1 and 15 of each 28 day cycle.