A Phase III, Multi-Center, Randomized, Controlled Study to Assess theEfficacy and Safety of ON 01910.Na Administered as a 72-Hour ContinuousIntravenous Infusion Every Other Week in Myelodysplastic SyndromePatients with Excess Blasts Relapsing After, or Refractory to, or Intolerantto Azacitidine or Decitabine
Purpose: The primary objective of the study is to compare overall survival in patients receiving 1800 mg/24 hr of ON 01910.Na via 72-hour continuous intravenous infusion per cycle with best supportive care to overall survival of patients receiving best supportive care in a population of patients with myelodysplastic syndrome with excess blasts (5% to 30% bone marrow blasts) having failed, being intolerant, or progressing after azacitidine or decitabine treatment.
Eligibility: Diagnosis of MDS confirmed within 6 weeks prior to study entry according to WHO criteria or FAB classification as follows: â?¢RAEB-1 (5% to 9% BM blasts) â?¢RAEB-2 (10% to 20% BM blasts) â?¢CMML (10% to 20% BM blasts) and WBC less than 13,000/Î¼L â?¢RAEB-t (21% to 30% BM blasts), meeting the following criteria: o WBC less than 25 x 109/L at study entry o Stable WBC at least 4 weeks prior to study
Study Overview/Treatment: This will be a Phase III open-label, randomized, controlled, multicenter study (up to 50 centers). At the start of treatment on this clinical trial, patients will receive the ON 01910.Na infusion every other week for first 16 weeks (8 doses). Then the frequency will decrease to the infusion being administered every 4 weeks. The patient will receive an unlimited number of cycles until progression or intolerable side effects. Treatments may be delayed due to delayed count recovery. Patients will receive a bone marrow at week 4 and then every 8 weeks. If the patient has prolonged myelosuppression a bone marrow may be performed.
06/18/2013 04:02 AM