A Phase I Dose Escalation Study of Oral SB939 Administered Alone or With Azacitidine

A Phase I Dose Escalation Study of Oral SB939 When Administered Thrice Weekly (Every Other Day) for 3 Weeks in a 4-week Cycle in Patients With Advanced Malignancies

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.

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.