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NCT02650804 · ClinicalTrials.gov registry record · Phase 2
BPM31510 Administered Intravenously With Gemcitabine in Advanced Pancreatic Cancer Patients
A Phase 2 study, sponsored by BPGbio.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT02650804: Completed Phase 2 study, sponsored by BPGbio.
NCT02650804 is a Phase 2 study that has completed, run by BPGbio. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02650804, a Phase 2 study, has completed, sponsored by BPGbio.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study 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.
Primary Outcome
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 sufficien
Interventions
- DRUG Gemcitabine
- DRUG BPM31510 Nanosuspension Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2016-07-06 |
| Est. Completion | 2019-06-11 |
| Phase | Phase 2 |
What the finished NCT02650804 record still lists
NCT02650804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Gemcitabine is the first listed.
NCT02650804 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02650804 about?
NCT02650804 is a clinical study titled "BPM31510 Administered Intravenously With Gemcitabine 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 t...
What is the current status of trial NCT02650804?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2016-07-06. Estimated completion is 2019-06-11.
What interventions are being tested in trial NCT02650804?
The interventions under investigation include: Gemcitabine (DRUG), BPM31510 Nanosuspension Injection (DRUG).
Who is sponsoring clinical trial NCT02650804?
This trial is sponsored by BPGbio, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02650804's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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