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A Phase III, Multi-Center, Randomized, Controlled Study to Assess the Efficacy and Safety of ON 01910.Na Administered as a 72 - Hour Continuous Intravenous Infusion Every Other Week in Myelodysplastic Syndrome Patients with Excess Blasts Relapsing After, or Refractory to, or Intolerant to Azacitidine or Decitabine
|Myelodysplastic Syndrome (MDS)
- The primary objective of the study is to compare overall survival (OS) in patients receiving 1800 mg/24 hr of ON 01910.Na via 72-hour continuous intravenous infusion administered every other week + best supportive care (BSC) to OS of patients receiving BSC 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.
- ≥ 18 years of age;
- Diagnosis of MDS confirmed within 6 weeks prior to study entry according to WHO criteria (Appendix 2) or FAB classification (Appendix 3);
- MDS classified as follows, according to WHO criteria and FAB classification:
- RAEB-1 (5% to 9% BM blasts)
- RAEB-2 (10% to 20% BM blasts)
- CMML (10% to 20% BM blasts) and WBC < 13,000/mL
- RAEB-t (21% to 30% BM blasts), meeting the following criteria:
- WBC < 25 x 10^9/L at study entry
- Stable WBC at least 4 weeks prior to study entry and not requiring intervention for WBC control with hydroxyurea, chemotherapy, or leukophoresis;
- At least one cytopenia (ANC < 1800/mL or platelet count < 100,000/�L or hemoglobin [Hgb] ^lt; 10 g/dL);
- Progression (according to 2006 IWG criteria; see Appendix 1) at any time after initiation of azacitidine or decitabine treatment during the past 2 years; or Failure to achieve complete or partial response or hematological improvement (according to 2006 IWG) after at least six 4-week cycles of azacitidine or four 6-week cycles of decitabine administered during the past 2 years; or Relapse after initial complete or partial response or hematological improvement (according to 2006 IWG criteria) observed after at least six 4-week cycles of azacitidine or four 6-week cycles of decitabine administered during the past 2 years; or Intolerance to azacitidine or decitabine defined by drug-related ≥ Grade 3 liver or renal toxicity leading to treatment discontinuation during the past 2 years;
- Has failed to respond to, relapsed following, not eligible, or opted not to participate in bone marrow transplantation;
- Off all other treatments for MDS for at least 4 weeks. Filgrastim (G-CSF) and erythropoietin are allowed before and during the study as clinically indicated;
- No medical need for induction chemotherapy;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 (see Appendix 5);
- Willing to adhere to the prohibitions and restrictions specified in this protocol;
- Patient (or patients legally authorized representative) must signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study.
- Anemia due to factors other than MDS (including hemolysis or gastrointestinal [GI] bleeding) unless stabilized for 1 week after RBC transfusion;
- Any active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast;
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia;
- Active infection not adequately responding to appropriate therapy;
- Total bilirubin ≥1.5 mg/dL not related to hemolysis or Gilbert's disease;
- Alanine transaminase (ALT)/aspartate transaminase (AST) ≥2.5 x upper limit of normal (ULN);
- Serum creatinine ≥2.0 mg/dL;
- Ascites requiring active medical management including paracentesis, or hyponatremia (defined as serum sodium value of < 130 mEq/L);
- Female patients who are pregnant or lactating;
- Patients who are unwilling to follow strict contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine device, double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) before entry and throughout the study;
- Female patients with reproductive potential who do not have a negative urine beta-human chorionic gonadotropin (βHCG) pregnancy test at screening;
- Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start;
- Uncontrolled hypertension (defined as a systolic pressure ≥160 mmHg and/or a diastolic pressure ≥110 mmHg);
- New onset seizures (within 3 months prior to the first dose of ON 01910.Na) or poorly controlled seizures;
- Any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy;
- Prior treatment with low-dose cytarabine during the past 2 years;
- Investigational therapy within 4 weeks of starting ON 01910.Na;
- Psychiatric illness or social situation that would limit the patient's ability to tolerate and/or comply with study requirements.
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