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NCT04299880 · ClinicalTrials.gov registry record · Phase 1
Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Protocols
A Phase 1 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT04299880: Completed Phase 1 study, sponsored by Sumitomo Pharma America.
NCT04299880 is a Phase 1 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04299880, a Phase 1 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
This is an open-label, multi-center, multi-national, non-randomized rollover study designed to allow continued access to napabucasin for patients who have participated in a Boston Biomedical-sponsored study and are being treated with napabucasin (monotherapy or combination) and who are deriving continued clinical benefit in the parent study at the time of closure.
Primary Outcome
Adverse Events, including clinically significant laboratory abnormalities, as characterized by type, frequency, severity (as graded by NCI CTCAE version 4.0), seriousness, and relationship to study therapy.
Interventions
- DRUG Nivolumab
- DRUG Paclitaxel
- DRUG Gemcitabine
- DRUG Nab-paclitaxel
- DRUG Napabucasin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2020-02-24 |
| Est. Completion | 2021-05-30 |
| Phase | Phase 1 |
What the finished NCT04299880 record still lists
NCT04299880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 5 interventions - of which Nivolumab is the first listed.
NCT04299880 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04299880 about?
NCT04299880 is a clinical study titled "Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Protocols". This is an open-label, multi-center, multi-national, non-randomized rollover study designed to allow continued access to napabucasin for patients who have participated in a Boston Biomedical-sponsored study and are being treated with napabucasin (monotherapy or combination) and who are deriving cont...
What is the current status of trial NCT04299880?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2020-02-24. Estimated completion is 2021-05-30.
What interventions are being tested in trial NCT04299880?
The interventions under investigation include: Nivolumab (DRUG), Paclitaxel (DRUG), Gemcitabine (DRUG), Nab-paclitaxel (DRUG), Napabucasin (DRUG).
Who is sponsoring clinical trial NCT04299880?
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 NCT04299880's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 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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