BPM31510IV-05 - BPM31510 in Advanced Pancreatic Cancer
Research type
Research Study
Full title
A Phase 2 Study of BPM31510 (Ubidecarenone, USP) Nanosuspension Injection Administered Intravenously with or without Gemcitabine as 2nd/3rdline therapy in Advanced Pancreatic Cancer Patients
IRAS ID
231488
Contact name
David Propper
Contact email
Sponsor organisation
Berg, LLC
Eudract number
2017-001470-42
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
108,093, IND NUMBER
Duration of Study in the UK
1 years, 8 months, 26 days
Research summary
Pancreatic cancer is a condition with 5 year survival of only 7%. Pancreatic cancer detection is often late, more than 80% of patients at the time of diagnosis have advanced disease. Currently, there are no curative treatments. Gemcitabine treatment, which is approved for pancreatic cancer treatment, demonstrated a survival of 5.7 months, and has been the mainstay in treating patients. Current treatment for advanced pancreatic cancer are clearly inadequate in achieving long term survival. Additional treatment strategies are desperately needed.
In this study we want to evaluate if a new treatment, BPM31510, alone or combined with gemcitabine will shrink patient’s tumours, or stop the tumour growing; the safety of BPM31510 will also be examined. The study is open-label, so both the study doctor and the patient will know the treatment they are receiving.
The active ingredient in BPM31510 is Coenzyme Q10 (CoQ10). CoQ10 is produced by the human body. BPM31510 inhibits multiple pathways, and laboratory studies showed selective killing of over 30 cancer cell lines with no damage to normal cells. In animal models BPM31510 demonstrated significant effects on survival and health against pancreatic tumours.
The patients recruited into the study will be over 18 and will have had at least one, but no more than two, treatments for pancreatic cancer.
Patients will be in the study for at least one cycle (Cycle 1 = 6 weeks, all other cycles = 4 weeks).
During each cycle BPM31510 is given as a 144-hour (6 day) continuous slow injection into a vein. BMP31510 is administered on Tuesdays and Fridays. Patients enrolled to receive combination therapy will receive gemcitabine on Mondays. Response to BPM31510 will be checked at the end of Cycle 2 and every 2 cycles thereafter using imaging techniques. Patients may continue to receive BPM31510 for a maximum of 12 cycles.
REC name
London - Brent Research Ethics Committee
REC reference
17/LO/1376
Date of REC Opinion
29 Sep 2017
REC opinion
Further Information Favourable Opinion