A Phase I Study Evaluating the Safety and Tolerability of Oral Clofarabine in Intermediate to High Risk Myelodysplastic Patients
The specific purpose of the study is to determine the safety, maximum tolerated dose (MTD)
and recommended Phase II dose of clofarabine in patients with MDS.
- We will start at a dose of 1 mg daily.
- We will treat a group of 3 patients with clofarabine at that dose level.
- If there are no severe side effects seen at that dose level, then the next group of 3
patients will receive a higher dose.
- Treatment of groups of 3 patients will continue at higher dose levels until severe
side-effects are noted.
- If more than 1 of the 3 patients experiences a severe side effect, dosing will be
stopped at that level.
- If only one of the three patients experience a severe side effect, then three more
patients will be treated, at that dose level and if they too experience severe side
effects, then dose escalation will be stopped and the maximum tolerated dose will be
- 10 more patients will be enrolled at the maximum tolerated dose.
- There will be up to 5 dose levels tested.
- We plan to test how much of the drugs are in the patient's blood at different times,
and the levels of certain proteins in their blood.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety, maximum tolerated dose (MTD) and recommended phase II dose of Clofarabine in patients with myelodysplastic syndrome (MDS).
Up to 6 months
Wetzler Meir, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|