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NCT01957735 · ClinicalTrials.gov registry record · Phase 1
BP31510 (Ubidecarenone,USP) Nanosuspension for Intravenous Injection to Patients With Solid Tumors
A Phase 1 study, sponsored by BPGbio.
- Completed
- Registry status
- Phase 1
- Development phase
- 97
- Enrollment target
NCT01957735: Completed Phase 1 study, sponsored by BPGbio.
NCT01957735 is a Phase 1 study that has completed, run by BPGbio. The registered enrollment target is 97 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01957735, a Phase 1 study, has completed, sponsored by BPGbio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 97 participants
- Enrollment target
Study Summary
This is a Phase 1a/b multicenter, open-label, non-randomized, dose-escalation study to examine the dose limiting toxicities (DLT) of BPM31510 administered as a 144-hour continuous intravenous (IV) infusion as monotherapy(treatment Arm 1) and in combination with chemotherapy (treatment Arm 2) in patients with solid tumors.
Primary Outcome
Dose limiting toxicities will be assessed during Cycle 1 (first four weeks of Arm 1 and 6 weeks for Arm 2) of the study. Blood samples for pharmacokinetic and pharmacodynamic analyses will be collected during each cycle of monotherapy and combination therapy. Urine samples for determination of BPM31510 renal clearance will be collected only during Cycle 1 of monotherapy and combination therapy. A PET scan will be performed within 2 weeks prior to starting treatment and after 2 weeks of BPM31510
Interventions
- DRUG BP31510 monotherapy
- DRUG BP31510 in combination with chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2013-10 |
| Est. Completion | 2017-02-01 |
| Phase | Phase 1 |
What the finished NCT01957735 record still lists
NCT01957735 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% higher).
The record links to 0 conditions, and to 2 interventions - of which BP31510 monotherapy is the first listed.
NCT01957735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01957735 about?
NCT01957735 is a clinical study titled "BP31510 (Ubidecarenone,USP) Nanosuspension for Intravenous Injection to Patients With Solid Tumors". This is a Phase 1a/b multicenter, open-label, non-randomized, dose-escalation study to examine the dose limiting toxicities (DLT) of BPM31510 administered as a 144-hour continuous intravenous (IV) infusion as monotherapy(treatment Arm 1) and in combination with chemotherapy (treatment Arm 2) in pati...
What is the current status of trial NCT01957735?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 97 participants. The study started on 2013-10. Estimated completion is 2017-02-01.
What interventions are being tested in trial NCT01957735?
The interventions under investigation include: BP31510 monotherapy (DRUG), BP31510 in combination with chemotherapy (DRUG).
Who is sponsoring clinical trial NCT01957735?
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 NCT01957735's enrollment target sits among peer trials
97 597th of 2000 higher than 1,401 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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