BPM31510 Administered Intravenously With Gemcitabine in Advanced Pancreatic Cancer Patients

NCT02650804 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BPM31510IV-05
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 12

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

Cancer; Advanced Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Treatment Response

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. (the appearance of new lesions is also considered progression); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Overall Response (OR) = CR + PR

  10 weeks (End of Cycle 2)

Secondary Outcomes (3)

• Overall Survival (OS)

  Up to study completion, an average of 1 year

• Time to Progression (TTP)

  Day 1, End of Cycle 2 (10 weeks) and every 2 cycles (every 8 weeks) through study completion, an average of 1 year

• Progression Free Survival (PFS)

  Up to study completion, an average of 1 year

Study Arms (2)

BPM31510 plus gemcitabine

EXPERIMENTAL

BPM31510 Nanosuspension Injection (40 mg/mL) starting dose of 110 mg/kg administered IV over 144 hours as 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday). Starting on Day 21-treatment 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.

Drug: BPM31510 Nanosuspension Injection; Drug: Gemcitabine

BPM31510 monotherapy

EXPERIMENTAL

BPM31510 Nanosuspension Injection (40 mg/mL) starting dose of 110 mg/kg administered IV over 144 hours as 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday).

Drug: BPM31510 Nanosuspension Injection

Interventions

BPM31510 Nanosuspension Injection DRUG

Also known as: Ubidecarenone, USP

BPM31510 monotherapy; BPM31510 plus gemcitabine

Gemcitabine DRUG

BPM31510 plus gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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 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 ductal carcinoma in situ (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 low molecular weight heparin (LMWH). Concomitant use of warfarin, even at prophylactic doses, is prohibited.

Sponsors & Collaborators

• BPGbio: lead

Study Sites (12)

Banner Health

Gilbert, Arizona, 85234, United States

Location

Mayo Clinic

Phoenix, Arizona, 85259-5499, United States

Location

Global Cancer Research Institute, Inc.

Gilroy, California, 95020, United States

Location

Sarcoma Oncology Research Center

Santa Monica, California, 90403, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Atlantic Health System Morristown Medical Center

Morristown, New Jersey, 07962, United States

Location

Vita Medical Associates, P.C.

Bethlehem, Pennsylvania, 18015, United States

Location

Mary Crowley Cancer Research Center

Dallas, Texas, 75230, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

The Beatson West of Scotland Cancer Centre

Glasgow, Strathclyde, G12 0YN, United Kingdom

Location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, NW3 2PF, United Kingdom

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Interventions

coenzyme Q10; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Head of Clinical Operations
• Organization: BPGbio Inc

clinicaltrials.connect@berghealth.com

6175880083

Study Officials

• Ramesh K Ramanathan, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Phase 2 multicenter, open-label, non-randomized to examine safety, effectiveness of combination of BPM31510 administered as 144-hour continuous intravenous (IV) infusion with gemcitabine in advanced pancreatic cancer patients as 2nd line therapy. Cycle 1 combination 6 weeks in duration for patients with BPM31510 administered twice wk. for 6 wk. and gemcitabine administered Days 21, 28 and 35. Cycles 2-12 are 4 wk. in duration with BPM31510 administered twice wk. for 4 wk. and gemcitabine administered Days 7, 14 and 21.

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: January 8, 2016
• Study Start: July 6, 2016
• Primary Completion: June 11, 2019
• Study Completion: June 11, 2019
• Last Updated: March 26, 2025
• Results First Posted: March 26, 2025

Record last verified: 2025-03

Locations

GB (3); US (9)