Pancreatic CancerPhase 2NCT02650804
BPM31510 Administered Intravenously With Gemcitabine in Advanced Pancreatic Cancer Patients
A Phase 2 study testing BPM31510 Nanosuspension Injection and Gemcitabine in people with Pancreatic Cancer, run by BPGbio at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- BPM31510 Nanosuspension Injection and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 6 Jul 2016to 11 Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States9 sites
Vita Medical Associates, P.C.
Bethlehem, Pennsylvania, 18015
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Mary Crowley Cancer Research Center
Dallas, Texas, 75230
Banner Health
Gilbert, Arizona, 85234
Global Cancer Research Institute, Inc.
Gilroy, California, 95020
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Atlantic Health System Morristown Medical Center
Morristown, New Jersey, 07962
Mayo Clinic
Phoenix, Arizona, 85259-5499
Sarcoma Oncology Research Center
Santa Monica, California, 90403
United Kingdom3 sites
The Beatson West of Scotland Cancer Centre
Glasgow, Strathclyde, G12 0YN
St Bartholomew's Hospital
London, EC1A 7BE
Royal Free London NHS Foundation Trust
London, NW3 2PF
About this study
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
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- BPM31510 Nanosuspension Injection, Gemcitabine
- Keywords
- Cancer, Advanced Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPM31510 Nanosuspension InjectionDrug
Also called Ubidecarenone, USP
GemcitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: BPM31510 Nanosuspension Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 weeks (End of Cycle 2)
Secondary outcomes (3)
Overall Survival (OS)
Overall Survival is defined as the number of months from the first dose of study drug to the date of death due to any cause.
Measured: Up to study completion, an average of 1 year
Time to Progression (TTP)
Time to Progression is defined as tumor progression measured from the first dose of study drug to the first documentation of progression.
Measured: 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)
The number of months from the first dose of study drug to the first documentation of progression or death due to any cause.
Measured: Up to study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study start6 Jul 2016
- Primary completion11 Jun 2019
- Study completion11 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- BPGbio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ramesh K Ramanathan, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650804
- Sponsor's protocol ID
- BPM31510IV-05
- Status last verified
- Mar 2025
- First submitted
- 19 Nov 2015
- Last updated
- 26 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02650804
- Acronym / sponsor ID
- BPM31510IV-05
- Conditions
- Pancreatic Cancer
- Keywords
- Cancer, Advanced Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- BPGbioIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2016 (actual)
- Primary completion
- 11 Jun 2019 (actual)
- Study completion
- 11 Jun 2019 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Posted 26 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| BPM31510 plus gemcitabine | Experimental | Drug: BPM31510 Nanosuspension Injection, Drug: GemcitabineBPM31510 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. |
| BPM31510 monotherapy | Experimental | Drug: BPM31510 Nanosuspension InjectionBPM31510 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPM31510 Nanosuspension InjectionAlso: Ubidecarenone, USP | Drug | BPM31510 monotherapy, BPM31510 plus gemcitabine |
| Gemcitabine | Drug | BPM31510 plus gemcitabine |
Primary outcome
Treatment Response
Time frame: 10 weeks (End of Cycle 2)
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
3 secondary outcomes
Overall Survival (OS)
Time frame: Up to study completion, an average of 1 year
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
Progression Free Survival (PFS)
Time frame: Up to study completion, an average of 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramesh K Ramanathan, MD principal investigator
Mayo Clinic
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BPM31510 Nanosuspension Injection and Gemcitabine in people with Pancreatic Cancer, run by BPGbio at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Response (time frame: 10 weeks (End of Cycle 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.