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NCT00854945 · ClinicalTrials.gov registry record · Phase 1
Study of 72-Hour Infusion of ON 01910.Na in Patients With MDS or AML
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Traws Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT00854945 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that has completed, run by Traws Pharma. The registered enrollment target is 36 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00854945, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, has completed, sponsored by Traws Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to evaluate the efficacy and safety of ON 01910.Na Concentrate when it is administered as an intravenous continuous infusion (IVCI) over 72 hours once every 2 weeks in a broad population of MDS patients. Rationale for this study is based on the activity observed in another study with ON 01910.Na in patients with refractory anemia with excess blasts (RAEB) 1 and 2 MDS. This study will examine ON 01910.Na in a broader population of MDS and AML patients. This phase I/II study will establish the Maximum Tolerated Dose (MTD) starting with a dose of 800 mg/m2 per day administered over 24 hours for 2 consecutive days as a continuous intravenous infusion, once a week for 3 weeks of a 4-week cycle and examine the efficacy and safety profile at the MTD.
Conditions Studied
Interventions
- DRUG ON 01910.Na
Study Locations (1)
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2009-01 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00854945
The ClinicalTrials.gov registry entry for NCT00854945 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (69% lower). The listed sponsor is Traws Pharma, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which ON 01910.Na is the first listed.
NCT00854945 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT00854945 about?
NCT00854945 is a clinical study titled "Study of 72-Hour Infusion of ON 01910.Na in Patients With MDS or AML". The primary objective of this study is to evaluate the efficacy and safety of ON 01910.Na Concentrate when it is administered as an intravenous continuous infusion (IVCI) over 72 hours once every 2 weeks in a broad population of MDS patients. Rationale for this study is based on the activity observe...
What is the current status of trial NCT00854945?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2009-01. Estimated completion is 2014-02.
What conditions does trial NCT00854945 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome.
What interventions are being tested in trial NCT00854945?
The interventions under investigation include: ON 01910.Na (DRUG).
Who is sponsoring clinical trial NCT00854945?
This trial is sponsored by Traws Pharma, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00854945 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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