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NCT01538537 · ClinicalTrials.gov registry record · Phase 1
Safety of ON 01910.Na as a 3-day Infusion in Patients With Advanced Cancer
A Phase 1 study, sponsored by Traws Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT01538537: Completed Phase 1 study, sponsored by Traws Pharma.
NCT01538537 is a Phase 1 study that has completed, run by Traws Pharma. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01538537, a Phase 1 study, has completed, sponsored by Traws Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the largest dose of ON 01910.Na (rigosertib sodium) that can be given safely as a 3-day continuous infusion once every 2 weeks (2-week cycle) in patients with advanced cancer.
Primary Outcome
DLTs are defined as: * Grade 3 non-hematological toxicity other than nausea, vomiting, diarrhea, fever, stomatitis, esophagitis/dysphagia. * Grade 3 nausea and vomiting uncontrolled by antiemetics; Grade 3 diarrhea uncontrolled by antidiarrheal agents; Grade 3 drug-induced fever uncontrolled by antipyretics. * Grade 3 stomatitis and/or esophagitis/dysphagia lasting \>3 days. * Grade 4 neutropenia or thrombocytopenia lasting \>5 days. * Episode of neutropenic fever, as defined in Protocol. * Fai
Interventions
- DRUG rigosertib sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2006-08 |
| Est. Completion | 2012-01 |
| Phase | Phase 1 |
What the finished NCT01538537 record still lists
NCT01538537 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 1 intervention - of which rigosertib sodium is the first listed.
NCT01538537 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01538537 about?
NCT01538537 is a clinical study titled "Safety of ON 01910.Na as a 3-day Infusion in Patients With Advanced Cancer". The primary objective of this study is to determine the largest dose of ON 01910.Na (rigosertib sodium) that can be given safely as a 3-day continuous infusion once every 2 weeks (2-week cycle) in patients with advanced cancer.
What is the current status of trial NCT01538537?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2006-08. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01538537?
The interventions under investigation include: rigosertib sodium (DRUG).
Who is sponsoring clinical trial NCT01538537?
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 NCT01538537's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 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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