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NCT01807546 · ClinicalTrials.gov registry record · Phase 2
Oral Rigosertib for Squamous Cell Carcinoma
A Phase 2 study, sponsored by Traws Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT01807546: Completed Phase 2 study, sponsored by Traws Pharma.
NCT01807546 is a Phase 2 study that has completed, run by Traws Pharma. The registered enrollment target is 64 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01807546, a Phase 2 study, has completed, sponsored by Traws Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine if tumors in patients with papillomavirus (HPV) positive or negative squamous cell carcinoma (SCC) that no longer responds to standard therapy will decrease in size following treatment with the investigational drug, rigosertib sodium (ON 01910.Na). A secondary objective is to determine if treatment with rigosertib causes any side effects. Rigosertib is an investigational drug, which means that it has not been approved by the U.S. Food and Drug Administration (FDA) to treat any diseases. We are studying rigosertib as a new anticancer drug. Tests that we have done in the laboratory suggest that rigosertib works by blocking cell division in cancer cells and causing them to die.
Primary Outcome
Outcome is defined as the number of patients with Complete Response (CR) or Partial Response (PR) per revised Response Evaluation Criteria In Solid Tumors (RECIST 1.1). Complete response (CR) is defined as disappearance of all target lesions. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Interventions
- DRUG rigosertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2013-03 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
What the finished NCT01807546 record still lists
NCT01807546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 1 intervention - of which rigosertib is the first listed.
NCT01807546 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01807546 about?
NCT01807546 is a clinical study titled "Oral Rigosertib for Squamous Cell Carcinoma". The primary objective of this study is to determine if tumors in patients with papillomavirus (HPV) positive or negative squamous cell carcinoma (SCC) that no longer responds to standard therapy will decrease in size following treatment with the investigational drug, rigosertib sodium (ON 01910.Na)....
What is the current status of trial NCT01807546?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2013-03. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01807546?
The interventions under investigation include: rigosertib (DRUG).
Who is sponsoring clinical trial NCT01807546?
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 NCT01807546's enrollment target sits among peer trials
64 996th of 2000 higher than 992 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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