A Study of BPM31510 (Ubidecarenone, USP) Nanosuspension Injection with Gemcitabine in Patients with Advanced Pancreatic Cancer
- Conditions
- Advanced Pancreatic CancerMedDRA version: 20.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2017-001470-42-GB
- Lead Sponsor
- BERG, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
Patients must meet the following criteria in order to be included in the clinical trial:
1. The patient has a histologically or cytologically confirmed metastatic pancreatic adenocarcinoma.
2. The patient has received:
at least one but no more than 2, prior standard or experimental therapies for metastatic pancreatic cancer*. If the patient has had prior gemcitabine treatment, the last date of gemcitabine administration-should be = 28 days prior to receiving study treatment. All patients who have previously received gemcitabine should be discussed with the medical monitor during screening.
3. The patient is at least 18 years old.
4. The patient has an ECOG performance status 0 - 1
5. Measurable tumour lesions according to RECIST 1.1 criteria
6. In the opinion of the Investigator, the patient has a life expectancy of > 3 months.
7. Sexually active patients and their partners agree to use an accepted method of contraception during the course of the study
8. Female patients of childbearing potential must have a negative pregnancy test within 1 week prior to beginning study treatment.
9. The patient has adequate organ and marrow function as follows:
•ANC = 1500 mm3, platelets = 100,000/mm3, hemoglobin = 9 g/dL,
•serum creatinine =upper limit of normal (ULN) or calculated creatinine clearance > 50 ml/min;
10. Total bilirubin = 1.5 X ULN(unless related to Gilbert’s Syndrome); 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.
11. The patient has serum electrolytes (including calcium, magnesium, phosphorous, sodium and potassium) within normal limits (supplementation to maintain normal electrolytes is allowed).
12. 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),
13. In the opinion of the Investigator, the patient is capable of understanding and complying with the protocol and has signed the informed consent document.
*For the purposes of this study, patients who have received at least one,
but no more than 2, prior standard therapies for locally advanced
pancreatic cancer and then transition to a diagnosis of metastatic
pancreatic cancer = 6 months post therapy may count the treatment for
locally advanced cancer as 1st line treatment for metastatic cancer.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 73
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7
The patient will be excluded from study participation if any of the following criteria are met:
1. 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.
2. 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)
3. 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).
4. Patients previously treated with gemcitabine: who discontinued gemcitabine due to toxicity in the first 6 weeks of prior treatment or is/was unable to tolerate a dose of 800 mg/m2 weekly at any point due to toxicity are not eligible.
5. The patient has received radiation to = 25% of his or her bone marrow within 4 weeks of the first dose of study drug.
6. The patient has received an investigational drug within 30 days of the first dose of study drug.
7. Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
8. History of other malignancies (except adequately treated Stage 1 cancer, cured basal cell carcinoma, superficial bladder cancer, breast ductal carcinoma in situ (DCIS) without invasive component, or carcinoma in situ of the cervix) unless documented free of cancer for =5 years.
9. 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.
10. The patient is pregnant or lactating.
11. 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.
12. The patient has an inability or unwillingness to abide by the study protocol or cooperate fully with the Investigator or designee.
13. The patient is receiving digoxin, digitoxin, lanatoside C or any type of digitalis alkaloids.
14. 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.
15. The patient has a known predisposition for bleeding such as von Willebrand’s disease or other such condition.
16. The patient requires therapeutic doses of any anticoagulant, including LMWH. Concomitant use of warfarin, even at prophylactic doses, is prohibited.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate the Overall Response Rate in patients treated with the combination of BPM31510 with gemcitabine;Secondary Objective: Evaluate Overall Survival; <br>Evaluate Progression-Free Survival overall and at around 10 weeks (equal to 2 cycles of treatment; cycle 1 = 6 weeks + cycle 2 = 4 weeks);<br>Evaluate Time to Progression (TTP); <br>Evaluate Tumor Response using Adaptive Molecular Responses (epi-genomic analysis (SNP or X-ome technology))<br>Determine the toxicity profile of BPM31510 in combination with gemcitabine when administered as a 144-hour intravenous (IV) infusion in patients with advanced pancreatic cancer. <br>Evaluate change in CA 19-9 levels.<br>Evaluate changes in patient reported Quality of Life at the end of Cycle 2, and at End of Study or early termination ;Primary end point(s): Overall Response Rate;Timepoint(s) of evaluation of this end point: Tumour assessments will be conducted at various timepoints during the trial
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Efficacy: Best response, disease control rate (CR+PR+SD), Duration of Response, Overall Survival, Progression-Free Survival (PFS), Time to Progression, and CA 19-9 level change. <br>Quality of Life: FACT-HEP self-administered patient questionnaire<br><br>Safety: Laboratory results, adverse events, vital signs, concomitant medications, concomitant procedures and ECG. ;Timepoint(s) of evaluation of this end point: Tumour assessments will be conducted at various timepoints during the trial