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NCT01168011 · ClinicalTrials.gov registry record · Phase 1
Safety, Pharmacokinetics and Clinical Activity of Oral Rigosertib in Solid Tumors
A Phase 1 study of Solid Tumor, sponsored by Traws Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 68
- Enrollment target
- 1
- Study location
NCT01168011: Completed Phase 1 study of Solid Tumor, sponsored by Traws Pharma.
NCT01168011 is a Phase 1 study of Solid Tumor that has completed, run by Traws Pharma. The registered enrollment target is 68 participants, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01168011, a Phase 1 study of Solid Tumor, has completed, sponsored by Traws Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 68 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase 1 study in which 2 to 72 patients with advanced cancer will receive oral doses of rigosertib, a new investigational (unapproved) anti-cancer drug. The objective of the study is to determine the highest dose of drug that can be given safely. The study will start by testing a low dose. If this dose is safe, then, higher and higher doses will be tested as long as the previous lower dose was safe. Safety will be determined by looking for any side effects or unusual laboratory values. It is important to know the highest safe dose so that additional studies can be done. The drug will be given in the form of capsules twice or three times a day for 21 consecutive days of 21-day cycles.
Primary Outcome
Adverse events (AEs) will be regarded as treatment emergent signs and symptoms (TESS) if they started on or after the date and time of administration of the first dose of study drug, or if they were present prior to the administration of the first dose of study drug and increased in severity during the study. Adverse events include clinical laboratory parameters (e.g., Hematology Panel and Serum Chemistry Panel). Other safety parameters include vital signs, physical examination findings, concomi
Conditions Studied
Interventions
- DRUG rigosertib
Study Locations (1)
Colorado
- University of Colorado at Denver Health and Sciences - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2010-07 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT01168011 record still lists
NCT01168011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which rigosertib is the first listed.
NCT01168011 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT01168011 about?
NCT01168011 is a clinical study titled "Safety, Pharmacokinetics and Clinical Activity of Oral Rigosertib in Solid Tumors". This is a phase 1 study in which 2 to 72 patients with advanced cancer will receive oral doses of rigosertib, a new investigational (unapproved) anti-cancer drug. The objective of the study is to determine the highest dose of drug that can be given safely. The study will start by testing a low dose....
What is the current status of trial NCT01168011?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2010-07. Estimated completion is 2015-12.
What conditions does trial NCT01168011 study?
This clinical trial studies the following conditions: Solid Tumor.
What interventions are being tested in trial NCT01168011?
The interventions under investigation include: rigosertib (DRUG).
Who is sponsoring clinical trial NCT01168011?
This trial is sponsored by Traws Pharma, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01168011 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01168011's enrollment target sits among peer trials
68 108th of 196 higher than 89 of 196 other Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor 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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A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
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