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NCT01538563 · ClinicalTrials.gov registry record · Phase 1
Safety of 24-Hour Infusion of ON 01910.Na in Patients With Advanced Cancer
A Phase 1 study, sponsored by Traws Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT01538563: Completed Phase 1 study, sponsored by Traws Pharma.
NCT01538563 is a Phase 1 study that has completed, run by Traws Pharma. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01538563, a Phase 1 study, has completed, sponsored by Traws Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
The primary purpose of this study is to determine the highest dose of ON 01910.Na that can be safely given as an intravenous infusion over 24 hours once a week in a 3-week cycle to patients with advanced solid tumors.
Primary Outcome
DLTs are defined as: * Grade 3 non-hematological toxicity other than nausea, vomiting, diarrhea, fever, stomatitis, esophagitis/dysphagia. * Recurrent grade 3 toxicity uncontrolled by optimal therapy or Grade 4 nausea, vomiting, diarrhea and fever. * Grade 3 stomatitis and/or esophagitis/dysphagia for \> 5 days. * Grade 4 neutropenia or thrombocytopenia for \> 5 days measured at least 2X 2-3 days apart. * Neutropenic fever, as defined in Protocol. * Failure to recover neutrophils (\> 1,500 per
Interventions
- DRUG rigosertib sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2006-06 |
| Est. Completion | 2011-11 |
| Phase | Phase 1 |
What the finished NCT01538563 record still lists
NCT01538563 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 1 intervention - of which rigosertib sodium is the first listed.
NCT01538563 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01538563 about?
NCT01538563 is a clinical study titled "Safety of 24-Hour Infusion of ON 01910.Na in Patients With Advanced Cancer". The primary purpose of this study is to determine the highest dose of ON 01910.Na that can be safely given as an intravenous infusion over 24 hours once a week in a 3-week cycle to patients with advanced solid tumors.
What is the current status of trial NCT01538563?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2006-06. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01538563?
The interventions under investigation include: rigosertib sodium (DRUG).
Who is sponsoring clinical trial NCT01538563?
This trial is sponsored by Traws Pharma, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01538563's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 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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