MC# 17-03 - A Phase II Study of BPM31510 (Ubidecarenone, USP) Nanosuspension Injection Administered Intravenously With Gemcitabine as Second/Third-Line Therapy in Advanced Pancreatic Cancer Patients
Agent(s): BPM31510, Gemcitabine
Disease Type(s): Pancreatic
Drug Classification(s): Targeted Therapy, Cellular Therapy
Molecular Target(s): BCL2
Mechanism of Action
BPM31510 is a metabolic pathway inhibitor. It stimulates mitochondrial pro-apoptotic bcl2 proteins to selectively induce cancer death.
In this study, the sponsor and investigators want to learn what the effects of BPM31510 when given in combination with Gemcitabine
- The patient has a histologically or cytologically confirmed metastatic pancreatic adenocarcinoma.
- The patient has undergone:
- at least one, but no more than 2 prior standard or experimental therapies, for metastatic pancreatic cancer (for enrollment into the combination therapy arm)
- The patient is at least 18 years old.
- The patient has an ECOG performance status 0 - 1.
- Measurable tumor lesions according to RECIST 1.1 criteria.
- 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.
- 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:
- ANC ≥ 1500 mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL,
- serum creatinine ≤ULN or calculated creatinine clearance > 50 ml/min;
- Total bilirubin ≤ 1.5 X ULN; alanine aminotransferase (ALT), aspartate transaminase (AST) ≤ 2.5 times the upper limit of normal 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,
- The patient is capable of understanding and complying with the protocol and has signed the informed consent document.
- The patient has uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure (NYHA class III and IV), uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- The patient has active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, unstable angina pectoris, or uncontrolled congestive heart failure (NYHA class III and IV).
- The patient has received chemotherapy within 2 weeks or radiotherapy within 4 weeks or has received nitrosoureas or mitomycin C within 6 weeks prior to the first dose of study drug. The patient must have recovered from treatment related toxicities to Grade 1 or less (other than alopecia).
- The patient has had prior treatment of gemcitabine as front-line therapy either as monotherapy or as combination chemotherapy. Prior adjuvant therapy with gemcitabine is allowed if recurrence occurred >12 months from the last date of adjuvant therapy.
- The patient has received radiation to ≥ 25% of his or her bone marrow within 4 weeks of the first dose of study drug.
- The patient has received an investigational drug within 30 days of the first dose of study drug.
- Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
- History of other malignancies (except adequately treated Stage 1 cancer, cured basal cell carcinoma, superficial bladder cancer, Breast DCIS, or carcinoma in situ of the cervix) unless documented free of cancer for ≥5 years.
- The patient has not recovered to grade ≤ 1 from adverse events (AEs) due to investigational drugs or other medications, which were administered more than 4 weeks prior to the first dose of study drug.
- The patient is pregnant or lactating.
- The patient is known to be positive for the human immunodeficiency virus (HIV). The effect of BPM31510 on HIV medications is unknown. Note: HIV testing is not required for eligibility, but if performed previously and was positive, the patient is ineligible for the study.
- The patient has an inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator or designee.
- The patient is receiving digoxin, digitoxin, lanatoside C or any type of digitalis alkaloids.
- The patient has uncontrolled or severe coagulopathies or a history of clinically significant bleeding within the past 6 months, such as hemoptysis, epistaxis, hematochezia, hematuria, or gastrointestinal bleeding.
- The patient has a known predisposition for bleeding such as von Willebrand’s disease or other such condition.
- The patient requires therapeutic doses of any anticoagulant, including LMWH. Concomitant use of warfarin, even at prophylactic doses, is prohibited.
- Dallas, TX - Mary Crowley Cancer Research - Medical City