Study in MDS Clause Samples

Study in MDS. A Phase 1 study in MDS patients (09-01) has recruited 21 patients at ▇▇▇▇▇▇▇ Cancer Center (▇▇. ▇▇▇▇▇▇▇▇) and Columbia (▇▇. ▇▇▇▇). These patients were treated with oral ON ▇▇▇▇▇.▇▇ in the 70 to 700 mg bid dose range for 2 weeks of a 3-week cycle. The drug has been well tolerated up to the 700mg dose. At the highest dose a few cases of dysuria (including one DLT) were noted. Based on this finding the cohort of 560mg bid was expanded. A total of 8 patients have been treated at this dose level with only one DLT (grade 3 diarrhea not responding to treatment) and this dose level has been established as the recommended Phase 2 dose. Detailed pharmacokinetics (absolute bioavailability and food effect) have been planned using this dose. Encouraging signs of activity have been detected, including bone marrow blast decreases and one case of transition to transfusion independence. The table below (May 2011) shows the duration of patient follow-up in the 280-700 mg dose range. Seven patients have completed at least 10 weeks of treatment, with the longest treatment duration of 30 weeks. · * * · * * · * * · * * · * * · * * · * * · * * · * * · * * · * * · * * · * * · * * · * * · * · * *