A Phase 2 Study of BPM31510 (Ubidecarenone, USP) Nanosuspension Injection Administered Intravenously With Gemcitabine as 2nd/3rdline Therapy in Advanced Pancreatic Cancer Patients
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.
• The patient has a histologically or cytologically confirmed metastatic pancreatic adenocarcinoma.
• The patient has undergone at least one prior, but no more than 2 prior standard, therapies for pancreatic cancer.If the patient has had prior gemcitabine treatment, the last date of gemcitabine administration-should be \> 3 months prior to screening for the study. All patients who have previously received gemcitabine should be discussed with the medical monitor during screening
• The patient is at least 18 years old.
• The patient has an Eastern Cooperative Oncology Group (ECOG) performance status
• Measurable tumor lesions according to RECIST 1.1 criteria (Section 10.2).
• In the opinion of the Investigator, the patient has a life expectancy of \> 3 months.
• Sexually active patients and their partners agree to use an accepted method of contraception during the course of the study (Appendix C:Guidelines Regarding Women of Childbearing Potential).
• Female patients of childbearing potential must have a negative pregnancy test within 1 week prior to beginning study treatment.
• The patient has adequate organ and marrow function as follows:
‣ absolute Neutrophil Count (ANC) ≥ 1500 mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL,
⁃ serum creatinine \< upper limit of normal (ULN);
⁃ total bilirubin \< 1.5 X (ULN) ; alanine aminotransferase (ALT), aspartate transaminase (AST) ≤ 2.5 times the upper limit of normal (ULN) if no liver involvement or ≤ 5 times the upper limit of normal with liver involvement.
• The patient has serum electrolytes (including calcium, magnesium, phosphorous, sodium and potassium) within normal limits (supplementation to maintain normal electrolytes is allowed).
• The patient has adequate coagulation: prothrombin time (PT) and an International Normalized Ratio (INR), and partial thromboplastin time (PTT) ≤ 1.5 times the upper limit of normal (ULN),
• In the opinion of the Investigator, the patient is capable of understanding and complying with the protocol and has signed the informed consent document.