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NCT01325441 · ClinicalTrials.gov registry record · Phase 1
A Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies
A Phase 1 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 1
- Development phase
- 565
- Enrollment target
NCT01325441: Completed Phase 1 study, sponsored by Sumitomo Pharma America.
NCT01325441 is a Phase 1 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 565 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (842% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01325441, a Phase 1 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 565 participants
- Enrollment target
Study Summary
This is an open label, single arm phase 1 dose escalation study and phase 2 study of BBI608 in combination with paclitaxel in patients with advanced malignancies.
Primary Outcome
Assessment of safety of napabucasin administered in participants with advanced malignancies for whom weekly paclitaxel was an acceptable option by reporting of adverse events and serious adverse events
Interventions
- DRUG Paclitaxel
- DRUG BBI608
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 565 participants |
| Start Date | 2011-04 |
| Est. Completion | 2021-06-01 |
| Phase | Phase 1 |
What the finished NCT01325441 record still lists
NCT01325441 is an interventional study that assigns participants to a tested intervention. The registered 565 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (842% higher).
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT01325441 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01325441 about?
NCT01325441 is a clinical study titled "A Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies". This is an open label, single arm phase 1 dose escalation study and phase 2 study of BBI608 in combination with paclitaxel in patients with advanced malignancies.
What is the current status of trial NCT01325441?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 565 participants. The study started on 2011-04. Estimated completion is 2021-06-01.
What interventions are being tested in trial NCT01325441?
The interventions under investigation include: Paclitaxel (DRUG), BBI608 (DRUG).
Who is sponsoring clinical trial NCT01325441?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01325441's enrollment target sits among peer trials
565 35th of 2000 higher than 1,966 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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