Safety of ON 01910.Na in Patients With Myelodysplasia
Status:
Completed
Trial end date:
2012-06-04
Target enrollment:
Participant gender:
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 biopsy.