BPM31510 Administered Intravenously With Gemcitabine in Advanced Pancreatic Cancer Patients

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Brief Title

BPM31510 Administered Intravenously With Gemcitabine in Advanced Pancreatic Cancer Patients

Official Title

A Phase 2 Study of BPM31510 (Ubidecarenone, USP) Nanosuspension Injection Administered Intravenously With Gemcitabine as 2nd/3rdline Therapy in Advanced Pancreatic Cancer Patients

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.
    

Detailed Description

      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.

      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.

      Cycles 2-12 are 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).

      Patients will continue BPM31510 in combination with gemcitabine, 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.

      Patients who experience disease progression but are, in the opinion of the investigator,
      receiving clinical benefit may continue BPM31510 as a monotherapy or in combination with
      gemcitabine or as a monotherapy pending approval from the Sponsor.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall Response Rate (ORR)

Secondary Outcome

 Overall Survival (OS)

Condition

Pancreatic Cancer

Intervention

BPM31510 Nanosuspension Injection

Study Arms / Comparison Groups

 BPM31510 plus gemcitabine
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

49

Start Date

July 6, 2016

Completion Date

June 11, 2019

Primary Completion Date

June 11, 2019

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ramesh K Ramanathan, MD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT02650804

Organization ID

BPM31510IV-05


Responsible Party

Sponsor

Study Sponsor

Berg, LLC


Study Sponsor

Ramesh K Ramanathan, MD, Principal Investigator, Mayo Clinic


Verification Date

September 2019