Clinical trialPhase 2Completed
BPM31510 Administered Intravenously With Gemcitabine in Advanced Pancreatic Cancer Patients
A Phase 2 Study of BPM31510 (Ubidecarenone, USP) Nanosuspension Injection Administered Intravenously With Gemcitabine as 2nd/3rdline Therapy in Advanced Pancreatic Cancer Patients
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 6 July 2016
- Expected end
- 11 June 2019
- Enrollment
- 45 participants
- Sites
- 12
- Primary outcomes
- Treatment Response
- Sponsor
- Industry
- Results posted
- 2025-03-26
- Last update
- 26 March 2025
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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. Cycle 1 of therapy is 6 weeks in duration with BPM31510 administered twice weekly on Tuesdays and Fridays for 6 weeks plus gemcitabine administered on Mondays, Days 21, 28 and 35. Cycles 2-12 are 4 weeks in duration with BPM31510 administered twice weekly on Tuesdays and Fridays for 4 weeks plus gemcitabine administered on Mondays, Days 7, 14 and 21. Response will be assessed after Cycle 2 (10 weeks) and patients who continue onto Cycles 2-12 will be assessed every 2 cycles (8 weeks). Patients will continue BPM31510 in combination with gemcitabine, for a maximum of 12 cycles in the absence of intolerable toxicity and progression. If gemcitabine is discontinued due to chemotherapy-related toxicity, patients may continue to receive BPM31510 as monotherapy. Patients who experience disease progression but are, in the opinion of the investigator, receiving clinical benefit may continue BPM31510 as a monotherapy or in combination with gemcitabine or as a monotherapy pending approval from the Sponsor.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Treatment Response [10 weeks (End of Cycle 2)]. Number, participants. Complete Response: BPM31510 Monotherapy (n=3): 0; BPM31510 Plus Gemcitabine (n=16): 0. Partial Response: BPM31510 Monotherapy (n=3): 0; BPM31510 Plus Gemcitabine (n=16): 0. Progressive Disease: BPM31510 Monotherapy (n=3): 2; BPM31510 Plus Gemcitabine (n=16): 8. Stable disease: BPM31510 Monotherapy (n=3): 1; BPM31510 Plus Gemcitabine (n=16): 8. Overall Response: BPM31510 Monotherapy (n=3): 0; BPM31510 Plus Gemcitabine (n=16): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [Up to study completion, an average of 1 year]. Median, Months (95% Confidence Interval). BPM31510 Monotherapy (n=3): 7.4 (4.4 to 9.5); BPM31510 Plus Gemcitabine (n=16): 7.3 (4.7 to 8.7).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Time to Progression (TTP) [Day 1, End of Cycle 2 (10 weeks) and every 2 cycles (every 8 weeks) through study completion, an average of 1 year]. Median, Months (95% Confidence Interval). BPM31510 Monotherapy (n=3): 2.4 (2.3 to 4.4); BPM31510 Plus Gemcitabine (n=16): 4.0 (2.3 to 4.8).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression Free Survival (PFS) [Up to study completion, an average of 1 year]. Median, Months (95% Confidence Interval). BPM31510 Monotherapy (n=3): 2.4 (2.3 to 4.4); BPM31510 Plus Gemcitabine (n=16): 4.0 (2.3 to 4.4).