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NCT01167166 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of 72-hour and 120-hour Infusion of Rigosertib in Acute Myeloid Leukemia (AML) and Acute Lymphoid Leukemia (ALL)
A Phase 1 study, sponsored by Traws Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01167166: Completed Phase 1 study, sponsored by Traws Pharma.
NCT01167166 is a Phase 1 study that has completed, run by Traws Pharma. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01167166, a Phase 1 study, has completed, sponsored by Traws Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
For patients with leukemia who have not responded to or have progressed after an initial response to standard therapy, therapeutic options are limited. Although responses to standard regimens do occur, durable remissions are achieved infrequently and current regimens are not curative in the majority of patients. Identification of active agents in patients with relapsed Acute Myeloid Leukemia (AML) ultimately affords the potential for use upfront as a component of induction regimens that may translate to improved outcome. Therefore, development of new agents is of critical importance. This study will look at a new, investigational agent, ON 01910.Na, to determine if it has the potential to help Patients with AML and Acute Lymphocytic Leukemia (ALL) and transformed Myeloproliferative Neoplasms.
Primary Outcome
DLT: adverse event possibly related that is: * Grade ≥ 3 non-hematological toxicity other than nausea, vomiting, diarrhea, fever, 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 metabolic abnormalities that are not controlled by optimal supportive care measures * Grade ≥ 3 stomatitis and/or esophagitis/dysphagia lasting \> 3 days * Marro
Interventions
- DRUG rigosertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-07 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
What the finished NCT01167166 record still lists
NCT01167166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which rigosertib is the first listed.
NCT01167166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01167166 about?
NCT01167166 is a clinical study titled "Safety and Efficacy of 72-hour and 120-hour Infusion of Rigosertib in Acute Myeloid Leukemia (AML) and Acute Lymphoid Leukemia (ALL)". For patients with leukemia who have not responded to or have progressed after an initial response to standard therapy, therapeutic options are limited. Although responses to standard regimens do occur, durable remissions are achieved infrequently and current regimens are not curative in the majority...
What is the current status of trial NCT01167166?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2010-07. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01167166?
The interventions under investigation include: rigosertib (DRUG).
Who is sponsoring clinical trial NCT01167166?
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 NCT01167166's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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