Myelodysplastic Syndrome Clinical Trial
A Phase I Dose Escalation Study of Oral SB939 Administered Alone or With Azacitidine
Summary
This is an open label, dose escalation study with 3 arms (Arms A, B, and C). Arm A will assess the safety and tolerability of escalating doses of SB939 in cohorts of patients with advanced solid tumors. Arm B will assess the safety and tolerability of escalating doses in cohorts of patients with advanced hematologic malignancies. Arm C will assess the safety and tolerability of SB939 in combination with standard azacitidine therapy.
Eligibility Criteria
Inclusion criteria:
Arms A & B:
Patients with solid tumors in Arm A and hematologic malignancies in Arm B that is classified as intermediate 1 or greater according to the International Prognostic Scoring System (IPSS) risk category for whom therapy is indicated;
ECOG performance status (PS) 0-2;
Patients must have adequate non-hematologic organ system function.
Arm C:
Patients with MDS that is classified as intermediate 1 or greater according to the International Prognostic Scoring System (IPSS) risk category for whom therapy is indicated;
Have not been treated with azacitidine and are a candidate for treatment with azacitidine;
ECOG performance status (PS) 0-2;
Patients must have adequate non-hematologic organ system function.
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There are 5 Locations for this study
Houston Texas, 77030, United States
Madison Wisconsin, 53792, United States
Singapore , 11907, Singapore
Singapore , 16061, Singapore
Singapore , 16960, Singapore
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