Long Term Safety Study of SyB L-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS) - Extension Study
Condition: Myelodysplastic Syndrome
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: SyB L-1101
Intervention description: SyB L-1101 (rigosertib sodium) will be administered intravenously 72 continuous hours (3 days), followed by 25-day observation period. The treatment period of 28 days (3 days of administration + 25 days of observation) constitutes 1 cycle. The dose at cycle 8 in the study 2011005 will be the dose (if needed, the dose can be reduced) at the first cycle in this study (cycle 9). From cycle 10 on, the dose of SyB L-1101 will be reduced, delayed, or discontinued according to adverse events and results of observation at the previous cycle.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This is an extension study study to investigate long term safety of SyB L-1101 when
      administered intravenously every 4 weeks to the patients who have completed 8 cycles in the
      study 2011005 whose purpose is to investigate tolerability of SyB L-1101 when administered
      intravenously in patients with recurrent/relapsed or refractory myelodysplastic syndrome.
      Antitumor effects will also be investigated in this study.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients must satisfy the following conditions listed below.

          1. Patients enrolled in the study 2011005 of SyB L-1101 in Patients With Myelodysplastic
             Syndrome.

          2. Patients who was not judged as disease progression* nor progressive disease/relapsed**
             at the end of the cycle 8 in the study 2011005. * hematologic remission according to
             IWG 2006 criteria ** hematologic improvement according to IWG 2006 criteria

          3. Patients who met the continuation criteria*** after Cycle 8 week 2 (Day 15±3) in the
             study 2011005.***defined in the study 2011005 protocol

          4. Patients who can be expected to survive at least three months or longer.

          5. Patients who have score of 0 to 2 in Eastern Cooperative Oncology Grou (ECOG)
             Performance Status (P.S.).

          6. Patients with adequate function in major organs (heart, lungs, liver, kidneys, etc.).

               -  Aspartate aminotransferase (AST): no more than 3.0 times the upper boundary of
                  the reference range at each institution

               -  Alanine aminotransferase (ALT): no more than 3.0 times the upper boundary of the
                  reference range at each institution

               -  Total bilirubin: no more than 1.5 times the upper boundary of the reference range
                  at each institution

               -  Serum creatinine: no more than 1.5 times the upper boundary of the reference
                  range at each institution

               -  ECG: no abnormal findings requiring treatment

               -  Echocardiography: no abnormal findings requiring treatment

          7. Patients who personally signed an informed consent document for participation in this
             study.

        Exclusion Criteria:

        Patients who satisfy any of the following conditions will not be enrolled in the study.

          1. Patients with anemia (haemolytic anaemia, gastrointestinal haemorrhage, etc.) caused
             by factors other than MDS.

          2. Patients with obvious infectious diseases (including viral infections).

          3. Patients with serious complications (liver failure, renal failure, etc.).

          4. Patients with a complication of serious heart disease (myocardial infarction, ischemic
             heart disease, etc.)

          5. Patients with a serious gastrointestinal condition (severe or significant
             nausea/vomiting, diarrhea, etc.)

          6. Patients with serious bleeding tendencies (disseminated intravascular coagulation
             (DIC), internal hemorrhage, etc.).

          7. Ascites requiring active medical management including paracentesis, or hyponatremia
             (defined as serum sodium value of <130 milliequivalent/L).

          8. Patients with an addiction to a legal or illegal drug, or with alcohol dependency.

          9. Patients who are nursing, pregnant or may become pregnant.

         10. Patients who have not consented to the following contraceptive measures. Patients will
             avoid sexual intercourse with sexual partners or should use the following
             contraceptive methods in these time periods: for male patients during the
             administration period of the trial and for six months after the end of administration;
             female patients during the administration period of the trial, and until a second
             menstrual period is confirmed after the end of administration (or in the case of
             female patients with no menstrual period, for two months after the end of
             administration). (1) Male patients:The patient will always use a condom. For effective
             contraception, it is recommended that the female partner also use the contraceptive
             methods for female patients. (2) Female patients: Female patients who may become
             pregnant should use one or more types of the following contraceptive methods. In
             addition, the male partner will always use a condom.

               -  Oral contraceptive (birth control pills)

               -  Intrauterine device (IUD)

               -  Tubal ligation

         11. Other patients judged to be unsuitable by an investigator or sub-investigator.