At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 45 enrolled
Drug / intervention
BPM31510 Nanosuspension Injection +1 moredrug
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.
A Phase 2 Study of BPM31510 (Ubidecarenone, USP) Nanosuspension Injection Administered Intravenously With Gemcitabine as 2nd/3rdline Therapy in Advanced Pancreatic Cancer Patients
In Brief
A Phase 2 clinical trial evaluating BPM31510 Nanosuspension Injection and Gemcitabine for Pancreatic Cancer. Completed, enrolled 45 participants across 12 sites in 2 countries.
Detailed Summary
This is a Phase 2 multicenter, open-label, non-randomized study to examine the safety and effectiveness of BPM31510 administered over 144-hours (two 72-hour 110mg/Kg doses) continuous intravenous (IV) infusion in combination with gemcitabine in advanced pancreatic cancer patients as 2nd / 3rd line therapy. The study will enroll up to 25 patients in the US and Europe.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Cancer
CountriesUnited Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartJul 2016
Primary CompletionJun 2019
TodayJul 2026
First PostedJan 8, 2016
Enrollment StartJul 6, 2016
Primary CompletionJun 11, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.5 years ago
Interventions
BPM31510 Nanosuspension Injectiondrug
Gemcitabinedrug