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BPM31510 Nanosuspension Injection (40 mg/mL) will be administered IV over 144 hours at the starting dose of 110 mg/kg. Each patient will receive 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday). The patient will be subsequently treated with gemcitabine IV once weekly at a starting dose of 1000 mg/m2.

Cycle 1 of combination therapy is 6 weeks in duration for patients with BPM31510 administered twice weekly on Tuesdays and Fridays for 6 weeks and 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 and gemcitabine administered on Mondays, Days 7, 14 and 21.

BPM31510 Nanosuspension Injection

Ramesh K Ramanathan, MD

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.

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.

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

Overall Response Rate is evaluated in patients treated with the combination of BPM31510 with gemcitabine. Tumor response of Partial Response (PR) or better, based on RECIST 1.1 criteria, will be assessed after Cycle 2 (10 weeks) and all patients who continue onto Cycles 2-12 will be assessed every 2 cycles (8 weeks).

Overall Survival is defined as the number of days from the first dose of study drug to the date of death due to any cause.

Time to Progression is defined as tumor progression measured from the first dose of study drug to the first documentation of progression.

The toxicity profile of BPM31510 in combination with gemcitabine when administered as a 144-hour intravenous (IV) infusion in patients with advanced pancreatic cancer. Toxicity will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4.02).

Evaluate the change in CA 19-9 levels in patients treated with BPM31510 in combination with gemcitabine when administered as a 144-hour intravenous (IV) infusion in patients with advanced pancreatic cancer.

The number of days from the first dose of study drug to the first documentation of progression or death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
BPM31510 Administered Intravenously With Gemcitabine in Advanced Pancreatic Cancer Patients	NCT02650804	Pancreatic Canc...	BPM31510 Nanosu... Gemcitabine	18 Years -	Berg, LLC
BPM31510 Administered Intravenously With Gemcitabine in Advanced Pancreatic Cancer Patients	NCT02650804	Pancreatic Canc...	BPM31510 Nanosu... Gemcitabine	18 Years -	Berg, LLC
BPM31510 Administered Intravenously With Gemcitabine in Advanced Pancreatic Cancer Patients	NCT02650804	Pancreatic Canc...	BPM31510 Nanosu... Gemcitabine	18 Years -	Berg, LLC
BPM31510 Administered Intravenously With Gemcitabine in Advanced Pancreatic Cancer Patients	NCT02650804	Pancreatic Canc...	BPM31510 Nanosu... Gemcitabine	18 Years -	Berg, LLC

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