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NCT02753127 · ClinicalTrials.gov registry record · Phase 3
A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,253
- Enrollment target
NCT02753127: Completed Phase 3 study, sponsored by Sumitomo Pharma America.
NCT02753127 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 1,253 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02753127, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,253 participants
- Enrollment target
Study Summary
This is an international multi-center, prospective, open-label, randomized, adaptive design phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).
Primary Outcome
Overall survival was defined as the time from randomization until death from any cause. Patients who are alive at the time of the interim or the final analyses or who have become lost to follow-up will be censored on the date the patient was last known to be alive.
Interventions
- DRUG Bevacizumab
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Irinotecan
- DRUG Napabucasin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,253 participants |
| Start Date | 2016-06 |
| Est. Completion | 2021-05-12 |
| Phase | Phase 3 |
What the finished NCT02753127 record still lists
NCT02753127 is an interventional study that assigns participants to a tested intervention. Its 1,253 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% higher).
The record links to 0 conditions, and to 5 interventions - of which Bevacizumab is the first listed.
NCT02753127 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02753127 about?
NCT02753127 is a clinical study titled "A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer". This is an international multi-center, prospective, open-label, randomized, adaptive design phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic colorectal cancer (CRC).
What is the current status of trial NCT02753127?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,253 participants. The study started on 2016-06. Estimated completion is 2021-05-12.
What interventions are being tested in trial NCT02753127?
The interventions under investigation include: Bevacizumab (DRUG), Fluorouracil (DRUG), Leucovorin (DRUG), Irinotecan (DRUG), Napabucasin (DRUG).
Who is sponsoring clinical trial NCT02753127?
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 NCT02753127's enrollment target sits among peer trials
1,253 206th of 2000 higher than 1,795 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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