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To assess tolerability of SyB C-1101 when administered orally BID for 21 days followed by a 7-day observation period in patients with recurrent/relapsed or refractory myelodysplastic syndrome in order to determine a recommended dose (RD). To assess safety, efficacy and pharmacokinetics.
Enrollment
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Inclusion and exclusion criteria
Patients who meet all of the following criteria are eligible for enrollment in the study:
Histologically or cytologically diagnosed as myelodysplastic syndrome (MDS) according to WHO criteria or FAB classification. For patients with RAEB in transformation (RAEB-t), peripheral WBC is ≦25,000 /mm3 and the disease is stable for at least 4 weeks.
Classified as Intermediate-1, Intermediate-2 or High-risk, according to IPSS classification.
Patients with a history of previous treatment of the target disease (e.g., immunosuppressive therapy, protein anabolic steroids, and chemotherapy including azacitidine and lenalidomide) and meet one of the followings:
Off all other treatment (including erythropoiesis stimulating agents) for MDS, for at least 4 weeks prior to enrollment and no carry-over (of antitumor effect) from previous treatment is expected as judged by Investigator. Transfusion is allowed, as clinically indicated.
Patients with expected survival of ≥3 months.
Patients aged 20 years or older (at the time of informed consent).
ECOG Performance Status (PS) of 0, 1 or 2
Patients with adequate major organ functions (including the heart, lungs, liver, and kidneys).
The patient must sign an informed consent form indicating that s/he understands the purpose of and procedure required for the study and is willing to participate in the study.
Primary purpose
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Interventional model
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10 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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