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
  • Phase(s): II
  • 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.  

Purpose

In this study, the sponsor and investigators want to learn what the effects of BPM31510 when given in combination with Gemcitabine

Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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.

Location

  • Dallas, TX - Mary Crowley Cancer Research - Medical City
More Info: https://clinicaltrials.gov/ct2/show/NCT02650804?term=BPM31510&rank=2

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Re: MC# 17-03