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

S*BIO85 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumors Hematologic Malignancies Myelodysplastic Syndrome

Interventions

SB939DRUG

SB939 taken orally in a 4-week cycle.

AzacitidineDRUG

Azacitidine taken orally with SB939 in a 4-week cycle

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

MD Anderson Cancer Center

Houston, Texas, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

National University Hospital

Singapore, Singapore

National Cancer Center

Singapore, Singapore

Outcomes

Primary Outcomes

To assess the safety and tolerability of SB939, administered orally every other day 3 times a week for 3 consecutive weeks, repeated every 4 weeks, either alone (Arms A and B), or in combination with azacitidine therapy in (Arm C).