1. SUB-TYPE OF MDS: All.
  2. SEVERITY OF MDS: All.
  3. NAME OF DRUG: Rigosertib
  4. Aims and benefits: This trial will investigate the survival of MDS patients receiving intravenous Rigosertib after failure of treatment with a Hypomethylating agent (HMA), Azacitidine (aza) or Decitabine (DEC)

  1. Main aims
    Secondary aims
  2. Main basic inclusion criteria:
    • MDS classified as follows:
      RAEB-1 per World Health Organization (WHO) MDS criteria (5% to 9% BM blasts)
      RAEB-2 per WHO MDS criteria (10% to 19% BM blasts)
      RAEB-t per French-American-British (FAB) classification (20% to 30% BM blasts)
    • Diagnosis of MDS confirmed within 8 weeks prior to the Screening Visit
    • At least one type of blood cells being low (cytopenia) (ANC < 1800/µL or platelet count < 100,000/µL or hemoglobin [Hgb] < 10 g/dL)
    • Progression at any time after initiation of AZA or DEC treatment OR
    • Failure to achieve complete or partial response or hematological improvement (HI)  after at least six cycles of AZA or either four cycles of DEC administered OR
    • Relapse after initial complete or partial response or HI
    • Duration of prior HMA therapy ≤ 9 months
    • Last dose of AZA or DEC within 6 months before the planned date of randomization; however, must be off these treatments for ≥ 4 weeks before randomization
    • Has failed to respond to OR relapsed following OR not eligible for OR opted not to participate in allogeneic stem cell transplantation
    • Off all treatments for MDS (including AZA and DEC) for ≥ 4 weeks before randomization; growth factors (G-CSF, erythropoietin and thrombopoietin) and transfusions are allowed before and during the study as clinically indicated
    • ECOG (how active you are able to be) performance status of 0, 1 or 2
  3. Main basic exclusion criteria:
    • Previous participation in a clinical study of IV or oral rigosertib; patients who failed screening for other rigosertib studies may be screened for participation
    • Eligible to receive induction chemotherapy, such as 7-10 days of cytosine arabinoside plus 2-3 days of an anthracycline, or high-dose cytarabine
    • Eligible to receive allogeneic stem cell transplantation
    • 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 or unstable angina pectoris
    • Active infection not adequately responding to appropriate therapy
    • Known HIV, hepatitis B or hepatitis C
    • Major surgery without full recovery or within 3 weeks before planned randomization;
    • Uncontrolled hypertension
    • New onset seizures (within 3 months before planned randomization) or poorly controlled seizures
    • Any other concurrent investigational agent or chemotherapy, radiotherapy, immunotherapy, or corticosteroids (except prednisone)
    • Treatment with cytarabine at any dose, lenalidomide, or any other therapy targeted to the treatment of MDS (other than growth factors and other supportive care measures) within 4 weeks of planned randomization
    • Investigational therapy within 4 weeks of planned randomization
    • Psychiatric illness or social situation that would limit the patient's ability to tolerate and/or comply with study requirements.
  4. Trial sites/locations and name of physician in charge of trial:
    - UK – Sites:
    Royal Bournemouth Hospital, Bournemouth;
    St Bartholomew's Hospital, Barts Health NHS Trust, London;
    Aberdeen Royal Infirmary, Aberdeen;
    King's College Hospital NHS Foundation Trust, London
    - Europe – Austria (Linz, Salzburg, Vienna), Croatia (Zagreb), France (La Roche Sur Yon, Nîmes, Pierre-Bénite), Spain (Barcelona)
    - USA – Illinois (Chicago), Maryland (Bethesda), Minnesota (Rochester), New York (New York City), and Texas (Dallas, Houston)
  5. More information: https://clinicaltrials.gov/ct2/show/NCT02562443

Please read information and always discuss trial information with your own physician.
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