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Trial record 4 of 6 for:    bpm31510

BPM31510 Administered Intravenously With or Without Gemcitabine in Advanced Pancreatic Cancer Patients

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ClinicalTrials.gov Identifier: NCT02650804
Recruitment Status : Recruiting
First Posted : January 8, 2016
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Berg, LLC

Brief Summary:
This is a Phase 2 multicenter, open-label, study to examine the safety and effectiveness of BPM31510 administered as a 144-hour 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: BPM31510 Nanosuspension Injection Drug: Gemcitabine Phase 2

Detailed Description:

This is a Phase 2 multicenter, open-label, study to examine the safety and effectiveness of BPM31510 administered as a 144-hour continuous intravenous (IV) infusion in combination with gemcitabine in advanced pancreatic cancer patients as 2nd / 3rd line therapy.

This study will occur in two parts. Part 1 of the study will enroll ten (10) patients. If at least one of ten patients treated experiences a Complete Response (CR) or Partial Response (PR), based on RECIST 1.1 criteria, after 2 cycles of treatment, then Part 2 of the study will enroll an additional 15 patients for a total of 25 patients. In the absence of at least one CR or PR, if at least 3 patients experience stable disease the Sponsor can choose to enroll the additional 15 patients into the applicable treatment arm(s) into the expansion stage.

BPM31510 Nanosuspension Injection (40 mg/mL) will be administered IV over 144 hours. Each patient will receive 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday). The dose for BPM31510 is 110 mg/Kg. Patients will also be treated with gemcitabine IV once weekly (starting at week 3) at a starting dose of 1000 mg/m2.

Cycle 1 of therapy is 6 weeks in duration with BPM31510 administered twice weekly on Tuesdays and Fridays for 6 weeks plus gemcitabine administered on Mondays, Days 21, 28 and 35 (combination therapy).

Cycles 2-12 are r 4 weeks in duration with BPM31510 administered twice weekly on Tuesdays and Fridays for 4 weeks plus gemcitabine administered on Mondays, Days 7, 14 and 21. Response will be assessed after Cycle 2 (10 weeks) and patients who continue onto Cycles 2-12 will be assessed every 2 cycles (8 weeks).

Toxicity will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4.02). Assessments of the antitumor activity of the combination will be performed at the end of Cycle 2 and every 2 cycles thereafter using standard techniques such as computerized tomography (CT) or magnetic resonance imaging (MRI) for patients with measurable disease. Response will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Patients who experience no unacceptable toxicity or disease progression, may receive additional 28-day cycles for up to 1 year.

Patients will continue treatment for a maximum of 12 cycles in the absence of intolerable toxicity and progression. If gemcitabine is discontinued due to chemotherapy-related toxicity, patients may continue to receive BPM31510 as monotherapy.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of BPM31510 (Ubidecarenone, USP) Nanosuspension Injection Administered Intravenously With or Without Gemcitabine as 2nd/3rdline Therapy in Advanced Pancreatic Cancer Patients
Study Start Date : February 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BPM31510 plus gemcitabine

BPM31510 Nanosuspension Injection (40 mg/mL) will be administered IV over 144 hours at the starting dose of 110 mg/kg. Each patient will receive 2 consecutive 72-hour infusions per week (Tuesday-Friday and Friday-Monday). The patient will be subsequently treated 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
Other Name: Ubidecarenone, USP

Drug: Gemcitabine



Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to study completion, an average of 1 year ]
    Overall Response Rate is evaluated in patients treated with the combination of BPM31510 with gemcitabine. Tumor response of Partial Response (PR) or better, based on RECIST 1.1 criteria, will be assessed after Cycle 2 (10 weeks) and all patients who continue onto Cycles 2-12 will be assessed every 2 cycles (8 weeks).


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to study completion, an average of 1 year ]
    Overall Survival is defined as the number of days from the first dose of study drug to the date of death due to any cause.

  2. Time to Progression (TTP) [ Time Frame: Day 1, End of Cycle 2 (10 weeks) and every 2 cycles (every 8 weeks) through study completion, an average of 1 year ]
    Time to Progression is defined as tumor progression measured from the first dose of study drug to the first documentation of progression.

  3. Toxicity profile of BPM31510 + gemcitabine (CTCAE v4.02) [ Time Frame: Every week through study completion, an average of 1 year ]
    The toxicity profile of BPM31510 in combination with gemcitabine when administered as a 144-hour intravenous (IV) infusion in patients with advanced pancreatic cancer. Toxicity will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4.02).

  4. Change in CA 19-9 levels [ Time Frame: Every month through study completion, an average of 1 year ]
    Evaluate the change in CA 19-9 levels in patients treated with BPM31510 in combination with gemcitabine when administered as a 144-hour intravenous (IV) infusion in patients with advanced pancreatic cancer.

  5. Progression Free Survival (PFS) [ Time Frame: 3 months (12 weeks) ]
    The number of days from the first dose of study drug to the first documentation of progression or death due to any cause.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650804


Contacts
Contact: Amy Stoll-D'Astice 602-570-2383 amys@crab.org
Contact: Stephanie Edwards 206-652-2267 stephe@crab.org

Locations
United States, Arizona
Banner Health Recruiting
Gilbert, Arizona, United States, 85234
Contact: Setu Kaushal, PhD    480-256-5411    Setu.Kaushal@BannerHealth.com   
Principal Investigator: Madappa Kundranda, MD, PhD         
Mayo Clinic Active, not recruiting
Phoenix, Arizona, United States, 85259-5499
United States, California
Global Cancer Research Institute, Inc. Recruiting
Gilroy, California, United States, 95020
Contact: Lynne A. Bui, MD       clinicaltrials@gcrioncology.com   
Principal Investigator: Lynne A. Bui, MD         
Sarcoma Oncology Research Center Recruiting
Santa Monica, California, United States, 90403
Contact: Victoria Chua-Alcala       vchua@sarcomaoncology.com   
Principal Investigator: Sant P Chawla, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Manuel Hidalgo Medina, MD       mhidalgo@bidmc.harvard.edu   
Principal Investigator: Manuel Hidalgo Medina, MD         
United States, New Jersey
Atlantic Health System Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07962
Contact: Nancy Ginder    973-971-6608    Nancy.Ginder@atlantichealth.org   
Principal Investigator: Angela Alistar, MD         
United States, Pennsylvania
Vita Medical Associates, P.C. Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Anna Niewiarowska, MD    610-866-0113    aaniewiarowska@gmail.com   
Contact: Lisa Gerber    610-866-0113 ext 11    lisagvitahemonc@gmail.com   
Principal Investigator: Anna Niewiarowska, MD         
United States, Texas
Mary Crowley Cancer Research Center Recruiting
Dallas, Texas, United States, 75230
Contact: Amy Jordan    972-566-3000    referral@marycrowley.org   
Principal Investigator: James Strauss, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Barb Dion       badion@mcw.edu   
Principal Investigator: Paul Ritch, MD         
United Kingdom
The Beatson West of Scotland Cancer Centre Recruiting
Glasgow, Strathclyde, United Kingdom, G12 0YN
Contact: Jeff Evans, MD       Jeff.Evans@ggc.scot.nhs.uk   
Principal Investigator: Thomas Evans, MD         
St Bartholomew's Hospital Recruiting
London, United Kingdom, EC1A 7BE
Contact       bhnt.cancerresearchdeliverygroup@nhs.net   
Principal Investigator: David Propper, MD         
Royal Free London NHS Foundation Trust Recruiting
London, United Kingdom, NW3 2PF
Contact: Roopinder Gillmore, MD       r.gillmore@nhs.net   
Principal Investigator: Roopinder Gillmore, MD         
Sponsors and Collaborators
Berg, LLC
Investigators
Principal Investigator: Ramesh K Ramanathan, MD Mayo Clinic

Responsible Party: Berg, LLC
ClinicalTrials.gov Identifier: NCT02650804     History of Changes
Other Study ID Numbers: BPM31510IV-05
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018

Keywords provided by Berg, LLC:
Cancer
Advanced Pancreatic Cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Coenzyme Q10
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances