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NCT00533416 · ClinicalTrials.gov registry record · Phase 1
Safety of ON 01910.Na in Patients With Myelodysplasia
A Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT00533416 is a Phase 1 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 14 participants.
The verdict
NCT00533416, a Phase 1 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This study will determine the highest dose of the experimental drug ON 01910.Na that can safely be given to patients with the bone marrow disorder myelodysplasia (MDS) and patients with refractory AML with trisomy 8. In this disease, the bone marrow can make some blood cells, but very few of these cells are released into the blood for use in the body. ON 01910.Na is an experimental drug that inhibits a protein called cyclinD1that is important for keeping MDS cells alive. In laboratory experiments, ON 01910.Na has acted against cyclinD1, causing MDS cells to die. The study will also evaluate how the body handles ON 01910.Na, the effect of the drug on MDS and AML and its side effects. Patients 18 to 85 years old with MDS or AML who do not have a suitable sibling donor for a marrow transplant or who are not willing to have a transplant may be eligible for this study. Participants receive ON 01910.Na in 2-week treatment cycles, with 3 to 5 days of drug infusion through a vein followed by 9 to 11 days of observation. To find the highest safe dose of ON 01910.Na, the first person enrolled in the study is given the smallest study dose of the drug for 3 days, followed 2 weeks later with a second dose for 3 days. If these doses are found safe, the next two people receive the same dose. If these subjects do well, the next group of patients receives the next higher dose level. The dose continues to be increased in groups of 3 to 6 subjects until the fourth and highest dose level is reached. Patients who do well on the treatment may receive an additional six cycles of ON 01910.Na (3 to 5 days of infusion once every other week for 12 weeks). Before, during and after the treatment period, patients are periodically evaluated and monitored with the following tests and procedures: * Physical examination and review of medical and medication history. * Blood and urine tests. * Pregnancy test for women of childbearing age. * Electrocardiogram (EKG) and chest X-ray. * Bone marrow bi
Interventions
- DRUG ON 01910 Na
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2007-09-14 |
| Est. Completion | 2012-06-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00533416
The ClinicalTrials.gov registry entry for NCT00533416 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ON 01910 Na is the first listed.
NCT00533416 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00533416 about?
NCT00533416 is a clinical study titled "Safety of ON 01910.Na in Patients With Myelodysplasia". This study will determine the highest dose of the experimental drug ON 01910.Na that can safely be given to patients with the bone marrow disorder myelodysplasia (MDS) and patients with refractory AML with trisomy 8. In this disease, the bone marrow can make some blood cells, but very few of these c...
What is the current status of trial NCT00533416?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2007-09-14. Estimated completion is 2012-06-04.
What interventions are being tested in trial NCT00533416?
The interventions under investigation include: ON 01910 Na (DRUG).
Who is sponsoring clinical trial NCT00533416?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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